BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 20 ML SYRINGE

    MDR report key: 9752078 · Received February 25, 2020

    Report

    Report Number
    3003152976-2020-00078
    Event Type
    Malfunction
    Date Received
    February 25, 2020
    Date of Event
    January 27, 2020
    Report Date
    March 26, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    30382903006138
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE UNUSED SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED AND THE STOPPER WAS OBSERVED TO BE IMPROPERLY ASSEMBLED, DISTORTED AGAINST THE BARREL WALL. AS A RESULT OF THIS DEFECT, A LEAKAGE CAN OCCUR AS THE SEAL IS NOT THE PROPER TIGHTNESS TO PREVENT LIQUID FROM PASSING BEHIND THE STOPPER. THE PRODUCT WAS DISASSEMBLED FOR FURTHER INSPECTION, THERE WAS NO DAMAGE NOTED IN THE PLUNGER ROD OR OTHER COMPONENTS THAT COULD HAVE CAUSED A LEAK. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 1911247, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THIS INCIDENT OCCURRED AS A RESULT OF IMPROPER ALIGNMENT OF THE PLUNGER/STOPPER TO THE BARREL DURING ASSEMBLY. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ 20 ML SYRINGE LEAKED DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PREPARING AN INFUSION, THE SYRINGE SHOWS A DEFECT AT THE PLUNGER WHICH LEAD TO A LEAKAGE DURING THE INJECTION.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PLASTIPAK¿ 20 ML SYRINGE LEAKED DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PREPARING AN INFUSION, THE SYRINGE SHOWS A DEFECT AT THE PLUNGER WHICH LEAD TO A LEAKAGE DURING THE INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216065 BD PLASTIPAK 20 ML SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 300613 1911247 30382903006138

    Patients

    Seq Age Sex Outcome Treatment
    1 Other