I125 SEEDS IN QUICKLINK, STERILE, 13.1 MBQ
Report
- Report Number
- 1018233-2024-06822
- Event Type
- Malfunction
- Date Received
- October 28, 2024
- Date of Event
- September 26, 2024
- Report Date
- November 14, 2024
- Manufacturer
- BARD BRACHYTHERAPY, INC. -1424526
- Product Code
- KXK
- PMA / PMN Number
- K093663
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H10: MANUFACTURING REVIEW: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. INVESTIGATION SUMMARY: ONE EMPTY MICK MAGAZINE WAS RETURNED FROM THE CUSTOMER AND LABELED AS BIOHAZARDOUS. UPON INITIAL INSPECTION, THE MAGAZINE HEAD WAS PARTIALLY UNSCREWED BUT STILL ATTACHED TO THE MAGAZINE BASE. A VISUAL INSPECTION DID NOT IDENTIFY ANY OTHER DEFECTS. WHEN THE MAGAZINE HEAD WAS TIGHTEN AND THEN AGITATED, THE HEAD DID NOT LOOSEN AGAIN. THE CARTRIDGE BASE / SEED TRACK DIMENSIONS WERE CONFIRMED WITHIN SPECIFICATION. THE ENTRANCE HOLE (TAPERED HOLE) DIMENSIONS WERE CONFIRMED WITHIN SPECIFICATION. THE EXIT HOLE (SMOOTH HOLE) DIMENSIONS WERE CONFIRMED WITHIN SPECIFICATION. FUNCTIONAL TESTING OF THE PLUNGER WAS COMPLETED, SATISFACTORILY, THE MAGAZINE PADDLE WOULD FULLY ROTATE WHEN RETRACTED INTO THE MAGAZINE HEAD, WITHOUT INTERFERENCE. NO FLASH OR OTHER DEFORMITIES WERE NOTED ON THE PADDLE/PLUNGER OR MAGAZINE BASE. 15 DUMMY SEEDS WITH SOURCECAPS WERE LOADED INTO THE MAGAZINE. THE MAGAZINE WAS PHYSICALLY AGITATED BY SHAKING, TAPPING THE MAGAZINE IN THE PALM OF THE HAND, AND TAPPING THE MAGAZINE ON THE TABLE. NO SEED MOVEMENT WAS NOTED - THERE WAS NO NOTICEABLE MOVEMENT OF THE SEED WITHIN THE SEED TRACK OF THE MAGAZINE. NO SEED PROTRUSION FROM THE MAGAZINE OCCURRED. THE MAGAZINE HEAD WAS LOOSENED SLIGHTLY (< 1/16 OF A TURN) AND AGITATED AGAIN. NO SEED MOVEMENT WAS NOTED - THERE WAS NO NOTICEABLE MOVEMENT OF THE SEED WITHIN THE SEED TRACK OF THE MAGAZINE. NO SEED PROTRUSION FROM THE MAGAZINE OCCURRED. THE MAGAZINE HEAD WAS RE-TIGHTENED AND THE SEEDS WERE DISPENSED. NO ISSUES WERE NOTED WHEN DISPENSING THE SEEDS. THEREFORE, THE RESULT OF THE INVESTIGATION IS UNCONFIRMED FOR THE REPORTED ISSUE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION. LABELING REVIEW: THE INFORMATION FOR USE STATES: THERE IS A WARNING STATEMENT "NEVER IMPLANT VISIBLY DAMAGED BRACHYSOURCE SEED IMPLANTS WITH SOURCECAPTM BIOABSORBABLE CAPS. BRACHYSOURCE SEED IMPLANTS WITH SOURCECAPTM BIOABSORBABLE CAPS SHOULD NEVER BE HANDLED ROUGHLY OR FORCED INTO ANY IMPLANT DEVICE, MAGAZINE OR NEEDLE. SUCH FORCE MAY DAMAGE THE WALL OF THE BRACHYTHERAPY SOURCE, POTENTIALLY CAUSING RELEASE OF I-125 INTO THE TISSUES SURROUNDING AN IMPLANTED BRACHYTHERAPY SOURCE OR INTO THE ENVIRONMENT." ADDITIONALLY, THERE IS A WARNING STATEMENT REGARDING MICK MAGAZINES "DO NOT HANDLE MICK CARTRIDGES BY THE SPRING-LOADED PLUNGER." "DO NOT OVERTIGHTEN THE ROUND MICK CARTRIDGES HEAD." "DO NOT USE FORCE ON SEEDS OR CARTRIDGES." THERE IS A CAUTION STATEMENT: "CAUTION: RADIATION PROTECTION. CAUTION: RADIATION PROTECTION BRACHYSOURCE SEED IMPLANTS WITH SOURCECAPTM BIOABSORBABLE CAPS PRELOADED IN NEEDLES OR MICK® CARTRIDGES ARE SHIPPED STERILE IN A SHIELDED SHIPPING CONTAINER DESIGNED TO ATTENUATE >(B)(4) OF THE PHOTONS FROM I-125. FOLLOWING REMOVAL FROM THE SHIPPING CONTAINER, STORE BRACHYSOURCE SEED IMPLANTS WITH SOURCECAPTM BIOABSORBABLE CAPS BEHIND APPROPRIATE SHIELDING UNTIL THEIR USE. THE HALF-VALUE THICKNESS OF LEAD FOR I-125 IS 0.025MM. THUS, A 0.25MM LEAD SHEET WILL PROVIDE >(B)(4) REDUCTION IN EXPOSURE BRACHYSOURCE SEED IMPLANTS WITH SOURCECAPTM BIOABSORBABLE CAPS PRELOADED IN NEEDLES OR MICK CARTRIDGES ARE SHIPPED STERILE IN A SHIELDED SHIPPING CONTAINER DESIGNED TO ATTENUATE >(B)(4) OF THE PHOTONS FROM I-125. FOLLOWING REMOVAL FROM THE SHIPPING CONTAINER, STORE BRACHYSOURCE SEED IMPLANTS WITH SOURCECAPTM BIOABSORBABLE CAPS BEHIND APPROPRIATE SHIELDING UNTIL THEIR USE. THE HALF-VALUE THICKNESS OF LEAD FOR I-125 IS 0.025MM. THUS, A 0.25MM LEAD SHEET WILL PROVIDE >(B)(4) REDUCTION IN EXPOSURE." H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
H10: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
IT WAS REPORTED THAT DURING A BRACHYTHERAPY PROCEDURE, THE SOURCE WAS ALLEGEDLY PROTRUDING FROM THE CARTRIDGE. IT WAS FURTHER REPORTED THAT THE SOURCE WAS PUSHED BACK INTO THE CARTRIDGE FROM THE OUTSIDE BUT THERE WAS A PROBLEM WITH EJECTION. REPORTEDLY, THE SOURCE WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
IT WAS REPORTED THAT DURING A BRACHYTHERAPY PROCEDURE, THE SOURCE WAS ALLEGEDLY PROTRUDING FROM THE CARTRIDGE. IT WAS FURTHER REPORTED THAT THE SOURCE WAS PUSHED BACK INTO THE CARTRIDGE FROM THE OUTSIDE BUT THERE WAS A PROBLEM WITH EJECTION. REPORTEDLY, THE SOURCE WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1891108 | I125 SEEDS IN QUICKLINK, STERILE, 13.1 MBQ | BRACHYTHERAPY SEEDS | KXK | BARD BRACHYTHERAPY, INC. -1424526 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |