SYRINGE 50ML LL AMBER
Report
- Report Number
- 3003152976-2020-00411
- Event Type
- Malfunction
- Date Received
- September 17, 2020
- Date of Event
- August 28, 2020
- Report Date
- November 19, 2020
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- FMF
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2020-11-11. H6: INVESTIGATION SUMMARY TWELVE SEALED SAMPLES OF LOT 2002254 WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR MOLDING DEFECTS WERE OBSERVED IN THE SYRINGE OR ANY COMPONENTS THAT MAY HAVE CONTRIBUTED TO THE REPORTED LEAK AND THE STOPPER WAS VERIFIED TO BE PROPERLY ASSEMBLED ONTO THE PLUNGER. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2002254, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 2002254 ALONG WITH THE TWELVE SAMPLES THAT WERE RETURNED WERE USED TO CONDUCT A LEAKAGE TEST. THE RETAINED SAMPLES WERE INSPECTED, NO DAMAGE OR DEFECTS WERE OBSERVED AND AGAIN THE STOPPERS WERE ALL PROPERLY ASSEMBLED ONTO THE PLUNGER ROD. IN ALL CASES THE PRODUCT FUNCTIONED AS INTENDED AND NO LEAKAGES OCCURRED. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES, INCLUDING TIGHTNESS VERIFICATION OF THE STOPPER AND LEAKAGE TESTING. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.
H6: INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2002254, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 2002254 WERE USED TO CONDUCT A LEAKAGE TEST. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS NOTED, THE STOPPER WAS PROPERLY ASSEMBLED ONTO THE PLUNGER, AND NO LEAK WAS IDENTIFIED. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES, INCLUDING TIGHTNESS VERIFICATION OF THE STOPPER AND LEAKAGE TESTING. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED THAT SYRINGE 50ML LL AMBER LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM CONTACTING YOU TODAY TO INFORM YOU OF A QUALITY DEFECT FOUND ON SEVERAL OF YOUR PRODUCTS. IN FACT, LEAKS AFTER SAMPLING WERE NOTED ON SEVERAL OCCASIONS ON SYRINGES IN THE SAME BATCH. THE DEVICES WERE SET ASIDE. CONCERNING THE DEFECTS OBSERVED DURING THE USE OF THE BD LUER-LOCK 50ML SYRINGES, THE LEAKAGE WAS OBSERVED AT THE PLUNGER LEVEL JUST AFTER SAMPLING. THE SYRINGES WERE IN CONTACT WITH THE PRODUCTS USUALLY HANDLED IN THE CHEMOTHERAPY PRODUCTION UNIT AND NO AGENT WAS CONTAMINATED (GLOVES WERE WORN). THE CONSEQUENCES WERE A REJECTION OF THE PREPARATION AND THE NEED TO GENERATE THE PRESCRIPTION AGAIN (CAUSING A DELAY IN DELIVERY). IT WAS DECIDED TO SUSPEND THE USE OF THE BATCH AFTER THE THIRD INCIDENT (BATCH QUARANTINED).
IT WAS REPORTED THAT SYRINGE 50ML LL AMBER LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM CONTACTING YOU TODAY TO INFORM YOU OF A QUALITY DEFECT FOUND ON SEVERAL OF YOUR PRODUCTS. IN FACT, LEAKS AFTER SAMPLING WERE NOTED ON SEVERAL OCCASIONS ON SYRINGES IN THE SAME BATCH. THE DEVICES WERE SET ASIDE. CONCERNING THE DEFECTS OBSERVED DURING THE USE OF THE BD LUER-LOCK 50ML SYRINGES, THE LEAKAGE WAS OBSERVED AT THE PLUNGER LEVEL JUST AFTER SAMPLING. THE SYRINGES WERE IN CONTACT WITH THE PRODUCTS USUALLY HANDLED IN THE CHEMOTHERAPY PRODUCTION UNIT AND NO AGENT WAS CONTAMINATED (GLOVES WERE WORN). THE CONSEQUENCES WERE A REJECTION OF THE PREPARATION AND THE NEED TO GENERATE THE PRESCRIPTION AGAIN (CAUSING A DELAY IN DELIVERY). IT WAS DECIDED TO SUSPEND THE USE OF THE BATCH AFTER THE THIRD INCIDENT (BATCH QUARANTINED).
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).
IT WAS REPORTED THAT SYRINGE 50 ML LL AMBER LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM CONTACTING YOU TODAY TO INFORM YOU OF A QUALITY DEFECT FOUND ON SEVERAL OF YOUR PRODUCTS. IN FACT, LEAKS AFTER SAMPLING WERE NOTED ON SEVERAL OCCASIONS ON SYRINGES IN THE SAME BATCH. THE DEVICES WERE SET ASIDE. CONCERNING THE DEFECTS OBSERVED DURING THE USE OF THE BD LUER-LOCK 50 ML SYRINGES, THE LEAKAGE WAS OBSERVED AT THE PLUNGER LEVEL JUST AFTER SAMPLING. THE SYRINGES WERE IN CONTACT WITH THE PRODUCTS USUALLY HANDLED IN THE CHEMOTHERAPY PRODUCTION UNIT AND NO AGENT WAS CONTAMINATED (GLOVES WERE WORN). THE CONSEQUENCES WERE A REJECTION OF THE PREPARATION AND THE NEED TO GENERATE THE PRESCRIPTION AGAIN (CAUSING A DELAY IN DELIVERY). IT WAS DECIDED TO SUSPEND THE USE OF THE BATCH AFTER THE THIRD INCIDENT (BATCH QUARANTINED).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1016101 | SYRINGE 50ML LL AMBER | SYRINGE | FMF | BECTON DICKINSON, S.A. | 2002254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |