BD SYRINGE 5ML LL EURO 125 S/C
Report
- Report Number
- 1213809-2024-00144
- Event Type
- Malfunction
- Date Received
- March 5, 2024
- Date of Event
- February 2, 2024
- Report Date
- May 23, 2024
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 30382903096498
- PMA / PMN Number
- K110771
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ONE SAMPLE AND ONE PHOTO OF 5ML EUROGRAPHIC SYRINGE WERE RECEIVED AND EVALUATED. THE SAMPLE HAS DAMAGE TO THE BARREL. THE BARREL WAS TESTED AND LEAKAGE PAST STOPPER WAS OBSERVED AT THE DAMAGED AREA OF THE BARREL. THE PHOTO SHOWS THE BARREL DAMAGED AT THE 1ML GRADUATION LINE OF THE BARREL. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE DAMAGED BARREL AND LEAKAGE PAST STOPPER DEFECTS IS ASSOCIATED WITH THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED BATCH NUMBER 3240901 SHOWING NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
ONE SAMPLE AND ONE PHOTO OF 5ML EUROGRAPHIC SYRINGE WERE RECEIVED AND EVALUATED. THE SAMPLE HAS DAMAGE TO THE BARREL. THE BARREL WAS TESTED AND LEAKAGE PAST STOPPER WAS OBSERVED AT THE DAMAGED AREA OF THE BARREL. THE PHOTO SHOWS THE BARREL DAMAGED AT THE 1ML GRADUATION LINE OF THE BARREL. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE DAMAGED BARREL AND LEAKAGE PAST STOPPER DEFECTS IS ASSOCIATED WITH THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED BATCH NUMBER 3240901 SHOWING NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.
DESCRIPTION OF NON-CONFORMITY: DURING SAMPLING OF A RADIOPHARMACEUTICAL ([68GA]GA-PSMA), THE SYRINGE WAS FOUND TO BE SPLIT. THE RADIOPHARMACEUTICAL THEREFORE LEAKED OUT OF THE SYRINGE. THE DEVICE WAS QUARANTINED FOR RADIOACTIVE DECAY. IT IS NO LONGER RADIOACTIVE. IN ORDER TO BE ABLE TO DISPENSE THE PRESCRIBED [68GA]GA-PSMA, ANOTHER SYRINGE OF THE SAME REFERENCE AND BATCH WAS PREPARED, INCREASING STAFF IRRADIATION. NO PATIENTS WERE EXPOSED DURING THIS INCIDENT. DATE OF OCCURRENCE, FREQUENCY: 02/02/2024. THE DEVICE(S) CONCERNED ARE KEPT IN THE FOLLOWING CONDITION: USED DECONTAMINATED.
IT WAS REPORTED THAT THE BD SYRINGE 5ML LL EURO 125 S/C BARREL/FLANGE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM FRENCH TO ENGLISH: "DURING SAMPLING OF A RADIOPHARMACEUTICAL ([68GA]GA-PSMA), THE SYRINGE WAS FOUND TO BE SPLIT. THE RADIOPHARMACEUTICAL THEREFORE LEAKED OUT OF THE SYRINGE. THE DEVICE WAS QUARANTINED FOR RADIOACTIVE DECAY. IT IS NO LONGER RADIOACTIVE. IN ORDER TO BE ABLE TO DISPENSE THE PRESCRIBED [68GA]GA-PSMA, ANOTHER SYRINGE OF THE SAME REFERENCE AND BATCH WAS PREPARED, INCREASING STAFF IRRADIATION." NO PATIENTS WERE EXPOSED DURING THIS INCIDENT. DATE OF OCCURRENCE, FREQUENCY: 02/02/2024. THE DEVICE(S) CONCERNED ARE KEPT IN THE FOLLOWING CONDITION: USED DECONTAMINATED.
DESCRIPTION OF NON-CONFORMITY: DURING SAMPLING OF A RADIOPHARMACEUTICAL ([68GA]GA-PSMA), THE SYRINGE WAS FOUND TO BE SPLIT. THE RADIOPHARMACEUTICAL THEREFORE LEAKED OUT OF THE SYRINGE. THE DEVICE WAS QUARANTINED FOR RADIOACTIVE DECAY. IT IS NO LONGER RADIOACTIVE. IN ORDER TO BE ABLE TO DISPENSE THE PRESCRIBED [68GA]GA-PSMA, ANOTHER SYRINGE OF THE SAME REFERENCE AND BATCH WAS PREPARED, INCREASING STAFF IRRADIATION. NO PATIENTS WERE EXPOSED DURING THIS INCIDENT. DATE OF OCCURRENCE, FREQUENCY: 02/02/2024 THE DEVICE(S) CONCERNED ARE KEPT IN THE FOLLOWING CONDITION: USED DECONTAMINATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1582572 | BD SYRINGE 5ML LL EURO 125 S/C | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | 3240901 | 30382903096498 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |