SYRINGE 50ML LL
Report
- Report Number
- 3003152976-2020-00088
- Event Type
- Malfunction
- Date Received
- February 27, 2020
- Date of Event
- February 3, 2020
- Report Date
- April 14, 2020
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- FMF
- PMA / PMN Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H.6 INVESTIGATION SUMMARY: A SAMPLE WAS RETURNED, THE PRODUCT WAS INDICATED TO BE CHEMO CONTAMINATED AND UNFORTUNATELY, COULD NOT BE EVALUATED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOTS 1910218 AND 1903233, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF EACH LOT WERE USED TO CONDUCT A LEAKAGE TEST. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS NOTED, AND NO LEAK WAS IDENTIFIED. 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 2 SAMPLES WITH CYTOSTATIC FLUID HAVE BEEN RECEIVED, SO THESE SAMPLES USED WITH CYTOSTATIC ARE NOT ALLOWED TO BE SENT OR ANALYZED FOR SAFETY REASONS. SO THIS SAMPLE IS GOING TO BE DESTROYED AND IT WON¿T BE INVESTIGATED. DHR OF LOT 1910218 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. DHR OF LOT 1903233 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. TEN RETAINED SAMPLES OF 50LL LOT 1910218 AND TEN RETAINED SAMPLES OF 50LL LOT 1903233 EVALUATED. UPON VISUAL INSPECTION OF THESE 10 SAMPLES, NO DAMAGE OR MOLDING DEFECT CAN BE OBSERVED IN ANY OF THEM THAT COULD CAUSE LEAKAGE. THE STOPPER IS CORRECTLY ASSEMBLED TO THE PLUNGER IN THE TEN SAMPLES. LEAK TEST IS ALSO CARRIED OUT WITH THE 20 RETAINED SAMPLES ACCORDING TO PROCEDURE PC-039 AND ISO 7886-1 ANNEX D. ALL OF THEM MEET ISO 7886-1 ANNEX D. THEY ARE DISASSEMBLED NOT OBSERVING ANY DAMAGE IN PLUNGER ROD THAT COULD HAVE CAUSED LEAKAGE. ACCORDING TO INSPECTION PLAN PROCEDURE JG-500, 200 UNITS ARE INSPECTED EVERY 2 PALLETS BY QUALITY CONTROL TEAM. IN ADDITION, FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE AND LOT SIZE ARE SAMPLED BY OPERATOR AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES (JG-301, JG-302, JG-303 AND JG-304): 1. VISUAL INSPECTION MOLDING: 2 INJECTIONS PER SHIFT. PRINTING: 32 SAMPLES PER TWO HOURS, AFTER ANY INTERVENTION IN THE EQUIPMENT AND ONCE AT THE BEGINNING OF THE SHIFT. ASSEMBLY: 32 SAMPLES PER TWO HOURS, AFTER ANY INTERVENTION IN THE EQUIPMENT AND ONCE AT THE BEGINNING OF THE SHIFT. PRIMARY PACKAGING: 1 ADVANCE-STEP (WITHOUT PRODUCT) PER HOUR, AFTER ANY INTERVENTION IN THE EQUIPMENT, AND ONCE AT THE BEGINNING OF THE SHIFT. SECONDARY PACKAGING: 1 SHELF-PACKAGE PER PALLET. 2. FUNCTIONAL INSPECTION: PRINTING: ONCE IN THE FIRST PALLET AND ONCE IN LAST PALLET OF THE LOT. ASSEMBLY: ONCE IN THE FIRST PALLET AND ONCE IN LAST PALLET OF THE LOT. PRIMARY PACKAGING: ONCE IN THE FIRST PALLET AND ONCE IN LAST PALLET OF THE LOT. SINCE NO MANUFACTURING DEFECT CAN BE OBSERVED IN RETAINED SAMPLES EVALUATED AND SINCE THEY MEET ISO 7886-1 ANNEX D FOR LEAK TEST, THE ROOT CAUSE OF THE ALLEGED DEFECT CANNOT BE DETERMINED.
H.6. INVESTIGATION: TWO SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION OF THE SAMPLES, NO DAMAGE WAS OBSERVED. THE PRODUCT WAS DISASSEMBLED FOR FURTHER INSPECTION, THERE WAS NO DAMAGE NOTED IN THE PLUNGER ROD OR OTHER COMPONENTS THAT COULD HAVE CAUSED A LEAKAGE. LEAKAGE TESTING WAS PERFORMED ON THE SAMPLES, ALL SAMPLES PERFORMED AS INTENDED AND NO LEAKAGE WAS OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOTS 1910218 AND 1903233, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF EACH LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS NOTED, AND NO LEAK WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME.
IT WAS REPORTED THAT THE SYRINGE 50ML LL LEAKED PAST THE STOPPER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: LEAKAGE AT THE PLUNGER WHEN SAMPLING SOLVENT OR CYTOTOXIC PRODUCT.
IT WAS REPORTED THAT THE SYRINGE 50ML LL LEAKED PAST THE STOPPER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: LEAKAGE AT THE PLUNGER WHEN SAMPLING SOLVENT OR CYTOTOXIC PRODUCT.
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1910218. MEDICAL DEVICE EXPIRATION DATE: 2024-09-30. DEVICE MANUFACTURE DATE: 2019-10-18. MEDICAL DEVICE LOT #: 1903233. MEDICAL DEVICE EXPIRATION DATE: 2024-02-29. DEVICE MANUFACTURE DATE: 2019-03-25. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT THE SYRINGE 50ML LL LEAKED PAST THE STOPPER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: LEAKAGE AT THE PLUNGER WHEN SAMPLING SOLVENT OR CYTOTOXIC PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 230519 | SYRINGE 50ML LL | SYRINGE | FMF | BECTON DICKINSON, S.A. | SEE H.10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |