BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL

    MDR report key: 11175811 · Received January 15, 2021

    Report

    Report Number
    3003152976-2021-00034
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    December 18, 2020
    Report Date
    February 8, 2021
    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

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: ONE USED SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER. THROUGH VISUAL INSPECTION OF THE SAMPLE, A LEAKAGE PAST THE STOPPER RIBS WAS OBSERVED. THE PRODUCT WAS DISASSEMBLED FOR FURTHER INSPECTION, THERE WAS NO DAMAGE OR MOLDING DEFECTS NOTED IN THE PLUNGER ROD OR OTHER COMPONENTS THAT COULD HAVE CAUSED THE LEAK AND THE STOPPER WAS VERIFIED TO BE PROPERLY ASSEMBLED ONTO THE PLUNGER ROD. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2003228, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 2003228 WERE USED TO CONDUCT A LEAKAGE TEST. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS NOTED, AND NO LEAK WAS OBSERVED. PRODUCT UNDERGOES VISUAL AND FUNCTIONAL INSPECTIONS THROUGHOUT MANUFACTURING, INCLUDING TIGHTNESS TESTING TO VERIFY THE STOPPER SEAL. RESULTS WERE REVIEWED FOR THE REPORTED LOT AND NO ISSUES WERE IDENTIFIED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 50ML LL LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE EVENT TOOK PLACE ON 18 DECEMBER DURING THE PREPARATION OF A POCKET OF DARATUMUMAB, A MONOCLONAL ANTIBODY. DURING THE COLLECTION OF DARATUMUMAB FROM THE SYRINGE, THE PLUNGER LEAKED AND THE LIQUID ENDED UP ON THE OTHER SIDE OF THE PLUNGER, THUS EXPOSING THE POUCH PREPARER TO THE DATUMUMAB (LEAKY PLUNGER SEAL). THE EVENTS TOOK PLACE IN THE CHEMOTHERAPY PREPARATION UNIT (CPU), SO THERE WERE NO CONSEQUENCES FOR THE PATIENT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 50ML LL LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE EVENT TOOK PLACE ON 18 DECEMBER DURING THE PREPARATION OF A POCKET OF DARATUMUMAB, A MONOCLONAL ANTIBODY. DURING THE COLLECTION OF DARATUMUMAB FROM THE SYRINGE, THE PLUNGER LEAKED AND THE LIQUID ENDED UP ON THE OTHER SIDE OF THE PLUNGER, THUS EXPOSING THE POUCH PREPARER TO THE DATUMUMAB (LEAKY PLUNGER SEAL). THE EVENTS TOOK PLACE IN THE CHEMOTHERAPY PREPARATION UNIT (CPU), SO THERE WERE NO CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78722 SYRINGE 50ML LL SYRINGE FMF BECTON DICKINSON, S.A. 2003228

    Patients

    Seq Age Sex Outcome Treatment
    1