BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE S2

    MDR report key: 8417351 · Received March 13, 2019

    Report

    Report Number
    3002682307-2019-00192
    Event Type
    Malfunction
    Date Received
    March 13, 2019
    Date of Event
    February 22, 2019
    Report Date
    April 30, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903019472
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR: 1803166: BD HAS REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. NO SAMPLE OR PICTURE AVAILABLE FOR EVALUATION. SINCE BD WAS UNABLE TO CONFIRM YOUR INDICATED FAILURE MODE, AND REVIEW OF DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT, NO ROOT CAUSE RELATED TO MANUFACTURING PROCESS IS DETERMINED. THE ABSENCE OF OTHER COMPLAINTS RELATED TO THIS ISSUE WERE RECEIVED ESTABLISHES THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. PROCESS MONITORING WILL BE CONDUCTED IN ORDER TO ENSURE THAT PRODUCT IS MAINTAINED WITHIN ESTABLISHED TOLERANCES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE OF A BD¿ SYRINGE S2 WAS BELOW THE LOWER LIMIT WHEN SAMPLING THE TAPER FIT OF THE BATCH. CUSTOMER¿S VERBATIM: ¿ THE DISTRIBUTOR FOUND THAT THE NEEDLE 5/5 WAS BELOW THE LOWER LIMIT WHEN SAMPLING THE TAPER FIT OF THE BATCH. ¿

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE OF A BD¿ SYRINGE S2 WAS BELOW THE LOWER LIMIT WHEN SAMPLING THE TAPER FIT OF THE BATCH. CUSTOMER¿S VERBATIM: ¿ THE DISTRIBUTOR FOUND THAT THE NEEDLE 5/5 WAS BELOW THE LOWER LIMIT WHEN SAMPLING THE TAPER FIT OF THE BATCH. ¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211478 BD SYRINGE S2 SYRING WITH NEEDLE FMF BECTON DICKINSON, S.A. 1803166 00382903019472

    Patients

    Seq Age Sex Outcome Treatment
    1 Other