BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ SYRINGE

    MDR report key: 7455213 · Received April 24, 2018

    Report

    Report Number
    1911916-2018-00155
    Event Type
    Malfunction
    Date Received
    April 24, 2018
    Date of Event
    March 30, 2018
    Report Date
    April 4, 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 · 1

    INVESTIGATION RESULTS: SUMMARY: A SAMPLE WAS RECEIVED FOR EVALUATION BY BD. A QUALITY ENGINEER WAS ABLE TO INSPECT THE SAMPLE AND DETERMINED THAT THERE WAS BARREL/FLANGE DAMAGE THUS VERIFYING THE REPORTED ISSUE. IT LOOKED LIKE THE DAMAGE WAS CAUSED BY THE PLUNGER ROD LABELER EXPERIENCING A VARIATION IN ITS NORMAL PROCESS. ANY ADJUSTMENTS WERE MADE BY THE ENGINEER AND IT WAS VERIFIED TO BE WORKING PROPERLY. A DEVICE HISTORY RECORD WAS PERFORMED ON THE REPORTED BATCH AND FOUND THAT ZERO DEFECTS WERE REPORTED DURING PRODUCTION. CONCLUSION: DHR/BHR REVIEW. THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH 7012589 DURING THIS PRODUCTION RUN. INVESTIGATION COMMENTS: ALL OUR INSPECTIONS PERFORMED WHILE MANUFACTURING THIS BATCH WERE ACCEPTED; NO REJECTIONS WERE DOCUMENTED. A SAMPLE WAS RECEIVED ON APRIL 12, 2018. IT CAME WITH NO PACKAGING FLOW WRAP, NO SALINE SOLUTION AND NO TIP CAP; IT HAS THE PLUNGER ROD-RUBBER STOPPER. THE BARREL LABEL CONFIRMS THE LOT#7012589. THE BARREL/FLANGE IS DAMAGED. PRODUCT WITHIN SPECIFICATION? YES, NO. CAPA NOT REQUIRED FOR THIS EVENT. ROOT CAUSE: ROOT CAUSE COULD NOT BE DETERMINED. THERE WERE NO QNS ISSUED DURING THE PRODUCTION OF THIS BATCH LISTED IN THE COMPLAINT. ALL INSPECTIONS WERE ACCEPTED DURING THE PRODUCTION OF THIS BATCH. THERE WAS NO ISSUE DOCUMENTED ABOUT BARREL/FLANGE DAMAGED. THE PLUNGER ROD LABELER EQUIPMENT POSSIBLY EXPERIENCED A VARIATION; ANYWAY, ADJUSTMENTS HAVE BEEN VERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FLANGE ON A BD POSIFLUSH¿ SYRINGE BROKE WHEN "PUSHING SALINE WATER WITHOUT FORCE" WHICH COULD LEAD TO INJURY OR LEAKAGE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299208 BD POSIFLUSH¿ SYRINGE SALINE FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 7012589

    Patients

    Seq Age Sex Outcome Treatment
    1 Other