BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH PRE-FILLED SALINE

    MDR report key: 7350689 · Received March 19, 2018

    Report

    Report Number
    1911916-2018-00105
    Event Type
    Malfunction
    Date Received
    March 19, 2018
    Date of Event
    March 8, 2018
    Report Date
    March 20, 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 SUMMARY: 15 SAMPLES WERE RECEIVED. 12 ARE WITH THE SEALED PACKAGING FLOW WRAP AND THREE (3) ARE WITH NO PACKAGING FLOW WRAP; ALL HAVE THE TIP CAP, THE PLUNGER ROD- RUBBER STOPPER, SALINE SOLUTION AND THE BARREL LABELS CONFIRM THE LOT# 7230998. ALL 15 SAMPLES HAVE THE BARREL FLANGE DAMAGED. DHR/BHR REVIEW: THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH 7230998 DURING THIS PRODUCTION RUN. ROOT CAUSE COULD NOT BE DETERMINED. THERE WERE NO QNS ISSUED DURING THE PRODUCTION OF THIS BATCH LISTED IN THE COMPLAINT. IT IS POSSIBLE THE PLUNGER ROD LABELER EQUIPMENT EXPERIENCED A VARIATION. HOWEVER, ADJUSTMENTS HAVE BEEN VERIFIED. 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 THAT THE NURSE FOUND FLANGE OF THE BD POSIFLUSH PRE-FILLED SALINE SYRINGE DAMAGED AFTER OPENING THE PLASTIC PACKAGE. FOUND BEFORE USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194143 BD POSIFLUSH PRE-FILLED SALINE SALINE FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 7230998

    Patients

    Seq Age Sex Outcome Treatment
    1 Other