BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ SYRINGE

    MDR report key: 7232006 · Received January 31, 2018

    Report

    Report Number
    1911916-2018-00012
    Event Type
    Malfunction
    Date Received
    January 31, 2018
    Date of Event
    January 11, 2018
    Report Date
    February 28, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    K161552
    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 IN THE COLUMBUS PLANT FOR EVALUATION. THE BARREL LABEL CONFIRMS THE LOT#7191751. IT HAS THE PLUNGER ROD-STOPPER, THE TIP CAP AND THE SALINE SOLUTION. IT HAS THE BARREL FLANGE DAMAGED THEREFORE FAILURE MODE IS VERIFIED. DHR REVIEW SHOWS THERE WERE NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH 7191751 DURING THIS PRODUCTION RUN. THIS IS THE FIRST COMPLAINT TO THE BATCH 7191751 FOR THE SAME DEFECT OR SYMPTOM. ALL OUR INSPECTIONS PERFORMED WHILE MANUFACTURING THIS BATCH WERE ACCEPTED. NO REJECTIONS WERE DOCUMENTED. THERE WERE NO QNS ISSUED DURING THE PRODUCTION OF THIS BATCH LISTED IN THE COMPLAINT. ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE ABOVE, NO FORMAL CORRECTIVE ACTION IS NECESSARY AT THIS TIME.

    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¿ SYRINGE THE CUSTOMER FOUND THE FLANGE DAMAGED WHEN OPENING THE UNIT PACKAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76413 BD POSIFLUSH¿ SYRINGE SALINE FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 7191751

    Patients

    Seq Age Sex Outcome Treatment
    1 Other