BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 20 ML SYRINGE WITH NEEDLE

    MDR report key: 10709360 · Received October 20, 2020

    Report

    Report Number
    3002682307-2020-00320
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    July 17, 2020
    Report Date
    October 1, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 190702 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. AS SAMPLES WERE NOT AVAILABLE FOR RETURN, TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR FURTHER EVALUATION BY OUR QUALITY ENGINEER TEAM. THE RETAINED SAMPLES WERE EXAMINED AND NO DEFECTS WERE OBSERVED. BASED ON THE INVESTIGATION RESULTS AN EXACT CAUSE FOR THIS REPORTED INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ 20 ML SYRINGE WITH NEEDLE LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PREPARING TO DISPENSE LIQUID FOR THE INFUSION PUMP, IT WAS FOUND THAT THE PRODUCT LEAKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173699 BD 20 ML SYRINGE WITH NEEDLE NEEDLE FMI BECTON DICKINSON, S.A. 1907202

    Patients

    Seq Age Sex Outcome Treatment
    1 Other