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Event Notification Report for March 20, 2008

U.S. Nuclear Regulatory Commission
Operations Center

Event Reports For
03/19/2008 - 03/20/2008

** EVENT NUMBERS **


44065 44069 44073 44076

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Hospital Event Number: 44065
Rep Org: DEPARTMENT OF VETERANS AFFAIRS
Licensee: VA MEDICAL CENTER - SAN FRANCISCO
Region: 4
City: SAN FRANCISCO State: CA
County:
License #: 03-23852-01VA
Agreement: Y
Docket:
NRC Notified By: EDWIN LIEDHOLDT
HQ OPS Officer: JEFF ROTTON
Notification Date: 03/15/2008
Notification Time: 00:07 [ET]
Event Date: 03/14/2008
Event Time: 08:00 [PDT]
Last Update Date: 03/15/2008
Emergency Class: NON EMERGENCY
10 CFR Section:
35.3045(a)(2) - DOSE > SPECIFIED EFF LIMITS
Person (Organization):
MARK RING (R3)
ANNA BRADFORD (FSME)

Event Text

POSSIBLE MEDICAL EVENT - LEAKING BRACHYTHERAPY SEEDS

"Description: Three patients were scheduled for transperineal permanent prostate seed brachytherapy implantations on March 14, 2008. Three separate packages of seeds in preloaded needles were received; surveys showed no surface contamination or contamination outside the inner sterile containers. On March 14, 2006, after 12 of 106 seeds were implanted in the first patient, a survey meter showed a small amount of radioactive contamination on the inside of the sterile packaging. This implantation was stopped. The survey meter showed contamination on the tips of three of the four needles that had been used, the greatest being 5000 cpm (420 Bq if an efficiency of 20% is assumed). This patient was administered stable iodine to block his thyroid in case of a leaking seed. The seed vendor was notified by telephone.

"To determine if the remaining patients should be implanted, the remaining two packages of seeds were opened and the interiors of the sterile packaging were surveyed. No contamination was found. An implant procedure was performed on the second patient. At the end of the procedure, the used needles were surveyed. A survey meter showed contamination on the tips of two of the needles; it was about 1000 cpm (83 Bq if an efficiency of 20% is assumed) on each. The seed vendor was again notified by telephone. A urine bioassay of this patient showed no radioactivity.

"Implantation of the third patient was cancelled.

"The needles of preloaded seeds were supplied by Best Medical International. The seeds contained I-125 and were Best Model 2301. The three batches of seeds were Lot Numbers 23017, 23019, and 23018 (not implanted).

"At this time, it is uncertain whether any seeds were leaking. A possibility is that the contents of the sterile packages were contaminated by the vendor, but no seeds were leaking.

"Effect on Patients: The VA is still evaluating this event. At this time, no adverse effects to the patients are expected.

"Patient notification: The permittee is in the process of ensuring that the referring physicians and patients were notified.

"We will notify the NRC Project Manager, Cassandra Frasier, of NRC Region III.

A "Medical Event" may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.

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General Information or Other Event Number: 44069
Rep Org: NC DIV OF RADIATION PROTECTION
Licensee: CAROLINAS MEDICAL CENTER
Region: 1
City: CHARLOTTE State: NC
County:
License #: 060-0014-3
Agreement: Y
Docket:
NRC Notified By: SHARN JEFFRIES
HQ OPS Officer: JOE O'HARA
Notification Date: 03/17/2008
Notification Time: 10:46 [ET]
Event Date: 03/14/2008
Event Time: [EDT]
Last Update Date: 03/17/2008
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
Person (Organization):
NEIL PERRY (R1)
MICHELE BURGESS (FSME)

Event Text

AGREEMENT STATE - LEAKING IODINE- 125 PROSTATE SEEDS

"Licensee identified 7 leaking Iodine-125 leftover prostate seeds from two patient doses: 3/11/08, 4 seeds. 3/12/08, 3 seeds. Patients were recalled, but showed no iodine uptake. Licensee phoned [state radiation protection officials]."

Seeds are approximately 0.3 micro Curies each.

Mills Pharmaceuticals (Core oncology-Oklahoma City) manufactures the seed sources. They are then sent to Medtech Diagnostic Services, Ft Meyers, Florida. Medtech loads the seeds into cartridges and sterilizes order. Medtech then sends the loaded cartridges to Carolinas Medical Center.

The state, licensee, and manufacturer are working together to determine where the seeds got damaged, whether at manufacturing, loading, or unloading.

"Incident Number 08-12."

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General Information or Other Event Number: 44073
Rep Org: WA DIVISION OF RADIATION PROTECTION
Licensee: WHIDBEY GENERAL HOSPITAL
Region: 4
City: COUPEVILLE State: WA
County:
License #: WM-M0217-1
Agreement: Y
Docket:
NRC Notified By: ARDEN SCROGGS
HQ OPS Officer: BILL HUFFMAN
Notification Date: 03/17/2008
Notification Time: 18:00 [ET]
Event Date: 03/13/2008
Event Time: [PDT]
Last Update Date: 03/17/2008
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
Person (Organization):
JACK WHITTEN (R4)
ANNA BRADFORD (FSME)

Event Text

AGREEMENT STATE REPORT OF LEAKING IODINE-125 SEED

The State of Washington Department of Health, Office of Radiation Protection, provided the following information via e-mail:

"On 10 March 2008 a patient was implanted with approximately 80 I-125 seeds. On 12 March 2008 (or 13 March 2008, it remains unclear as of this writing), the patient complained of pain and difficulty urinating. A cauterization was performed via the urethra. Upon removal of the cauterization equipment, some seeds also exited via the urethra. One seed, in particular, was visibly different from the rest. This seed was, upon closer observation, noted to be shorter than the others and, in fact, had been damaged. Cause of the damage (shear force during insertion or perhaps a result of the cauterization) has yet to be determined.

"A survey of the area including the patient using a Technical Associates TBM-3 showed contamination of the equipment and bodily fluids, while an external reading directly over the thyroid showed levels above background."

The activity of the damaged I-125 seed was less than 300 microcuries. Licensee is assessing possible overexposure to the patient, organ dose calculations underway by licensee consultant.

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Hospital Event Number: 44076
Rep Org: DEPARTMENT OF VETERANS AFFAIRS
Licensee: DEPARTMENT OF VETERANS AFFAIRS
Region: 4
City: NORTH LITTLE ROCK State: AR
County:
License #: 03-23853-01VA
Agreement: Y
Docket:
NRC Notified By: THOMAS HUSTON
HQ OPS Officer: STEVE SANDIN
Notification Date: 03/19/2008
Notification Time: 10:24 [ET]
Event Date: 03/18/2008
Event Time: 12:00 [CDT]
Last Update Date: 03/19/2008
Emergency Class: NON EMERGENCY
10 CFR Section:
20.1906(d)(1) - SURFACE CONTAM LEVELS > LIMITS
Person (Organization):
JACK WHITTEN (R4)
STEVE ORTH (R3)
NEIL PERRY (R1)
MICHELE BURGESS (NMSS)

Event Text

RECEIPT OF PACKAGE WITH SURFACE CONTAMINATION

The following script was provided in a telephone call to the NRC Operations Center:

"My name is Thomas Huston with the Department of Veterans Affairs, VHA National Health Physics Program. This report involves NRC master materials license No. 03-23853-01VA.

"I am calling to report receipt of three packages of radioactive material with removable surface contamination on the outside of the package greater than the limits in 10 CFR 71.87(i).

"The three packages were received at approximately 1:00 PM ET, March 18, 2008 by the VA Medical Center in West Palm Beach, FL.

"Wipe tests performed on the three packages indicated the following removable contamination levels: 24700 dpm/cm2, 12880 dpm/cm2, and 35570 dpm/cm2 as compared to the regulatory limit of 22 dpm/cm2.

"The three packages contained Co-57 flood sources and were received from a commercial vendor, Eckert & Ziegler (Isotope Products Laboratories), of Valencia, CA. The final delivery was by common carrier. The final delivery carrier was notified of the contaminated packages at approximately 1630 hrs ET on March 18, 2008 by the VA Medical Center's Radiation Safety Officer. The vendor was notified of the contamination at approximately 1730 hr on March 18, 2008 by the VA Medical Center's Radiation Safety Officer.

"The radionuclide involved is believed to be Co-57; however, additional confirmatory measurements are being made.

"Additional information: The Department of Veterans Affairs coordinates all reports to the NRC from the NHPP Director's Office located in North Little Rock, AR. NRC oversight for the VA Master Materials licensee is assigned to NRC Region 3. Address of permittee involved in this event:

"VA Medical Center, 7305 North Military Trail, West Palm Beach, Florida 33410, VHA Permit Number 09-25328-01."

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Thursday, March 29, 2012