BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK SYRINGE

    MDR report key: 8375174 · Received February 27, 2019

    Report

    Report Number
    3003152976-2019-00186
    Event Type
    Malfunction
    Date Received
    February 27, 2019
    Date of Event
    February 7, 2019
    Report Date
    March 4, 2019
    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
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE UNUSED SAMPLE AND THREE PHOTO SAMPLES WERE PROVIDED TO OUR QUALITY ENGINEER TEAM FOR EVALUATION. UPON VISUAL INSPECTION OF THE SAMPLES, IT WAS OBSERVED THAT THE STOPPER WAS INCORRECTLY ASSEMBLED TO THE PLUNGER, DISTORTED AGAINST THE BARREL WALL. THE RETURNED SAMPLE WAS DISASSEMBLED FOR FURTHER EVALUATION, NO DAMAGED OR MOLDING DEFECT IN THE PLUNGER ROD WAS INDICATED THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. A DEVICE HISTORY WAS PERFORMED AND FOUND NO NO-CONFORMANCES RELATED TO THE REPORTED ISSUE DURING PRODUCT OF BATCH 1811234. THIS ISSUE WAS DETERMINED TO HAVE OCCURRED AS A RESULT OF IMPROPER ALIGNMENT OF THE PLUNGER/STOPPER TO THE BARREL DURING ASSEMBLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD PLASTIPAK¿ SYRINGE THE RUBBER STOPPER DEFORMED

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). 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 BEFORE USE OF THE BD PLASTIPAK¿ SYRINGE THE RUBBER STOPPER DEFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166109 BD PLASTIPAK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1811234

    Patients

    Seq Age Sex Outcome Treatment
    1 Other