PD103 SEEDS LOADED IN MICK CARTRIDGES, STERILE
Report
- Report Number
- 1018233-2016-01623
- Event Type
- Malfunction
- Date Received
- November 16, 2016
- Report Date
- January 19, 2017
- Manufacturer
- BARD BRACHYTHERAPY, INC. -1424526
- Product Code
- KXK
- PMA / PMN Number
- K060636
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIST
Narratives
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD 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 BARD. THE DEVICE WAS NOT RETURNED.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD 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 BARD. THE DEVICE WAS NOT RETURNED
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD 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 BARD. THE DEVICE WAS NOT RETURNED.
THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "THIS IS A SINGLE USE DEVICE. DO NOT RESTERILIZE ANY PORTION OF THIS DEVICE. REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO DEVICE FAILURE AND/OR LEAD TO INJURY, ILLNESS, OR DEATH OF THE PATIENT. DO NOT STORE THE SEED / SOURCECAPTM ASSEMBLIES OR BIOSPACER¿ SEEDING SPACER AT TEMPERATURES ABOVE 40C." (B)(4). THE INFORMATION PROVIDED BY BARD 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 BARD. THE DEVICE WAS NOT RETURNED.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD 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 BARD. THE DEVICE WAS NOT RETURNED.
IT WAS REPORTED THAT THE SEEDS WERE FUSED TOGETHER. THE COMPLAINANT STATED THAT A CARTRIDGE WAS DROPPED DURING THE PROCEDURE, AND WAS LATER STERILIZED AT THE FACILITY. FOLLOWING THE RE-STERILIZATION, THE SEEDS WERE FUSED, AND AN ATTEMPT TO UN-FUSE AND USE THE SEEDS WAS UNSUCCESSFUL. AS A RESULT, A TOTAL OF 65 OF 80 PLANNED SEEDS WERE IMPLANTED. DUE TO THE MALFUNCTION, THE NEEDLES WERE NOT USED FOR IMPLANTATION. IT WAS ALSO REPORTED THAT THE DECISION WAS MADE TO ADDRESS DOSE VARIANCE USING AN ALREADY PLANNED EXTERNAL BEAM TREATMENT THAT WAS SCHEDULED FOR APPROXIMATELY FOUR WEEKS LATER.
IT WAS REPORTED THAT THE SEEDS WERE FUSED TOGETHER. THE COMPLAINANT STATED THAT A CARTRIDGE WAS DROPPED DURING THE PROCEDURE AND WAS LATER STERILIZED AT THE FACILITY. FOLLOWING THE RE-STERILIZATION, THE SEEDS WERE FUSED, AND AN ATTEMPT TO UN-FUSE AND USE THE SEEDS WERE UNSUCCESSFUL. AS A RESULT, A TOTAL OF 65 OF 80 PLANNED SEEDS WERE IMPLANTED. DUE TO THE MALFUNCTION, THE NEEDLES WERE NOT USED FOR IMPLANTATION. THE DECISION WAS THEN MADE TO ADDRESS DOSE VARIANCE USING ALREADY PLANNED EXTERNAL BEAM TREATMENT APPROXIMATELY FOUR WEEKS LATER.
IT WAS REPORTED THAT THE SEEDS WERE FUSED TOGETHER. THE COMPLAINANT STATED THAT A CARTRIDGE WAS DROPPED DURING THE PROCEDURE, AND WAS LATER STERILIZED AT THE FACILITY. FOLLOWING THE RE-STERILIZATION, THE SEEDS WERE FUSED, AND AN ATTEMPT TO UN-FUSE AND USE THE SEEDS WAS UNSUCCESSFUL. AS A RESULT, A TOTAL OF 65 OF 80 PLANNED SEEDS WERE IMPLANTED. DUE TO THE MALFUNCTION, THE NEEDLES WERE NOT USED FOR IMPLANTATION. IT WAS ALSO REPORTED THAT THE DECISION WAS MADE TO ADDRESS DOSE VARIANCE USING AN ALREADY PLANNED EXTERNAL BEAM TREATMENT THAT WAS SCHEDULED FOR APPROXIMATELY FOUR WEEKS LATER.
IT WAS REPORTED THAT THE SEEDS WERE FUSED TOGETHER. THE COMPLAINANT STATED THAT A CARTRIDGE WAS DROPPED DURING THE PROCEDURE, AND WAS LATER STERILIZED AT THE FACILITY. FOLLOWING THE RE-STERILIZATION, THE SEEDS WERE FUSED, AND AN ATTEMPT TO UN-FUSE AND USE THE SEEDS WAS UNSUCCESSFUL. A TOTAL OF 65 OF 80 PLANNED SEEDS WERE IMPLANTED. DUE TO THE MALFUNCTION, THE NEEDLES WERE NOT USED FOR IMPLANTATION. IT WAS ALSO REPORTED THAT THE DECISION WAS MADE TO ADDRESS DOSE VARIANCE USING AN ALREADY PLANNED EXTERNAL BEAM TREATMENT THAT WAS SCHEDULED FOR APPROXIMATELY FOUR WEEKS LATER.
IT WAS REPORTED THAT A CARTRIDGE WAS DROPPED DURING THE PROCEDURE AND WAS LATER STERILIZED AT THE FACILITY. FOLLOWING THE RE-STERILIZATION, THE SEEDS WERE FUSED, AND AN ATTEMPT TO UN-FUSE AND USE THE SEEDS WERE UNSUCCESSFUL. AS A RESULT, A TOTAL OF 65 OF 80 PLANNED SEEDS WERE IMPLANTED. DUE TO THE MALFUNCTION, THE NEEDLES WERE NOT USED FOR IMPLANTATION. THE DECISION WAS THEN MADE TO ADDRESS DOSE VARIANCE USING ALREADY PLANNED EXTERNAL BEAM TREATMENT ABOUT FOUR WEEKS LATER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 758186 | PD103 SEEDS LOADED IN MICK CARTRIDGES, STERILE | SEEDS | KXK | BARD BRACHYTHERAPY, INC. -1424526 | BBAQ0133 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |