BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 7571560 · Received June 5, 2018

    Report

    Report Number
    1911916-2018-00258
    Event Type
    Malfunction
    Date Received
    June 5, 2018
    Date of Event
    May 15, 2018
    Report Date
    June 5, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    K982558
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY: ONE SAMPLE WAS RECEIVED FOR EVALUATION BY ONE OF OUR QUALITY ENGINEERS. IT HAS NO PACKAGING FLOW WRAP. IT CAME IN A DISPOSABLE PLASTIC GLOVE. IT HAS THE PLUNGER ROD-RUBBER STOPPER, IT HAS NO TIP CAP, NEITHER SALINE SOLUTION. THE BARREL LABEL CONFIRMS THE LOT# 7241671. IT HAS THE LUER DAMAGED THEREFORE FAILURE MODE IS VERIFIED. THE TIP CAP CUP STATION MOST LIKELY HAD A PIECE OF PLASTIC FROM ANOTHER TIP CAP. THIS PIECE OF PLASTIC COULD HAVE INDUCED THE DAMAGE SHOWN ON THIS SAMPLE. A DEVICE HISTORY REVIEW WAS COMPLETED AND THERE WERE NO DOCUMENTED ISSUES FOR THE COMPLAINT OF BATCH 7241671 DURING THIS PRODUCTION RUN. THERE WERE NO QUALITY NOTIFICATIONS ISSUED DURING THE PRODUCTION OF THIS BATCH LISTED IN THE COMPLAINT. ALL INSPECTIONS WERE ACCEPTED DURING THE PRODUCTION OF THIS BATCH. CONCLUSION: INVESTIGATION COMMENTS: ALL OUR INSPECTIONS PERFORMED WHILE MANUFACTURING THIS BATCH WERE ACCEPTED; NO REJECTIONS WERE DOCUMENTED. UPDATE MAY 24, 2018. ONE SAMPLE WAS RECEIVED. IT HAS NO PACKAGING FLOW WRAP, IT CAME IN A DISPOSABLE PLASTIC GLOVE, IT HAS THE PLUNGER ROD-RUBBER STOPPER, IT HAS NO TIP CAP, NEITHER SALINE SOLUTION. THE BARREL LABEL CONFIRMS THE LOT# 7241671. IT HAS THE LUER DAMAGE. PRODUCT WITHIN SPECIFICATION? YES? NO? ALL INSPECTIONS WERE ACCEPTED DURING THE PRODUCTION OF THIS BATCH. THERE WAS NO ISSUE DOCUMENTED ABOUT BARREL/FLANGE DAMAGED / LEAKAGE. ROOT CAUSE: ROOT CAUSE COULD NOT BE DETERMINED. THERE WERE NO QNS ISSUED DURING THE PRODUCTION OF THIS BATCH LISTED IN THE COMPLAINT. THE TIP CAP CUP STATION MOST LIKELY HAD A PIECE OF PLASTIC FROM ANOTHER TIP CAP; THIS PIECE OF PLASTIC COULD HAVE INDUCED THE DAMAGE SHOWN ON THIS SAMPLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE NURSE FOUND THE TIP OF THE BARREL BROKEN ON A BD POSIFLUSH¿ NORMAL SALINE SYRINGE WHEN OPENING THE PACKAGE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410940 BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 7241671

    Patients

    Seq Age Sex Outcome Treatment
    1 Other