BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ SYRINGE

    MDR report key: 7280270 · Received February 19, 2018

    Report

    Report Number
    1911916-2018-00043
    Event Type
    Malfunction
    Date Received
    February 19, 2018
    Date of Event
    February 1, 2018
    Report Date
    March 1, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A SAMPLE WAS RECEIVED. IT HAS THE PLUNGER ROD AND RUBBER STOPPER. THE TIP CAP IS LOOSE (UNSCREWED), IT HAS NO SALINE SOLUTION, AND THE BARREL LABEL CONFIRMS THE LOT # 7191751. IT HAS THE FLANGE DAMAGED THEREFORE FAILURE MODE IS VERIFIED. ROOT CAUSE COULD NOT BE DETERMINED. THERE WERE NO QNS ISSUED DURING THE PRODUCTION OF THIS BATCH LISTED IN THE COMPLAINT. THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH 7191751 DURING THIS PRODUCTION RUN. ALL INSPECTIONS AND TESTING WERE ACCEPTED DURING THE PRODUCTION OF THIS BATCH. CAPA NOT REQUIRED FOR THIS EVENT.

    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 BEFORE USE OF THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE CUSTOMER FOUND THE PLUNGER ROD DAMAGED WHEN UNIT PACKAGE WAS OPENED. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124640 BD POSIFLUSH¿ SYRINGE SALINE FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 7191751

    Patients

    Seq Age Sex Outcome Treatment
    1 Other