BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 7530603 · Received May 21, 2018

    Report

    Report Number
    1911916-2018-00208
    Event Type
    Malfunction
    Date Received
    May 21, 2018
    Date of Event
    April 26, 2018
    Report Date
    May 18, 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: SIX SAMPLES WERE RETURNED TO BD FOR EVALUATION. A QUALITY ENGINEER INSPECTED THE RETURNED SAMPLES AND DETERMINED THAT FIVE OF THEM HAD BARREL/FLANGE DAMAGE THUS VERIFYING THE REPORTED ISSUE. ONE SAMPLE APPEARED TO NOT HAVE ANY VISUAL FLANGE/BARREL DAMAGE AND WAS TESTED FOR LEAKING. IT PASSED THE LEAK TEST, THEREFORE, BD WAS UNABLE TO VERIFY THE DEFECT OF LEAKAGE. THE CAUSE OF THE BARREL/FLANGE DAMAGED WAS DETERMINED TO BE A VARIATION WITH THE PLUNGER ROD LABELER. THE ENGINEER INSPECTED THE EQUIPMENT AND MADE ANY NECESSARY ADJUSTMENTS. A DEVICE HISTORY REVIEW WAS PERFORMED ON THE REPORTED LOT AND FOUND ZERO DEFECTS OR QUALITY NOTIFICATIONS RECORDED DURING THIS PRODUCTION RUN. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. CONCLUSION: DHR/BHR REVIEW THERE WERE NO DOCUMENTED ISSUES FOR THE COMPLAINT OF BATCH 7241671 DURING THIS PRODUCTION RUN. INVESTIGATION COMMENTS: ALL OUR INSPECTIONS PERFORMED WHILE MANUFACTURING THIS BATCH WERE ACCEPTED; NO REJECTIONS WERE DOCUMENTED. UPDATE MAY 9, 2018. SIX (6) SAMPLES WERE RECEIVED. NONE HAVE THE PACKAGING FLOW WRAP. ALL OF THEM HAVE THE PLUNGER ROD- RUBBER STOPPER, FOUR (4) HAVE TIP CAP, ALL HAVE NO SALINE SOLUTION, THE BARREL LABELS CONFIRM THE LOT# 7241671. FIVE (5) OF THEM HAVE THE BARREL FLANGE DAMAGED. PRODUCT WITHIN SPECIFICATION? YES? NO? 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. ROOT CAUSE. THE PLUNGER ROD LABELER EQUIPMENT POSSIBLE EXPERIENCED A VARIATION; ANYWAY, ADJUSTMENTS HAVE BEEN VERIFIED. CAPA NOT REQUIRED FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED A NURSE FOUND THE FLANGE BROKEN ON A BD POSIFLUSH¿ NORMAL SALINE SYRINGE WHEN OPENING THE PLASTIC PACKAGE. THE DEVICE FUNCTIONED PROPERLY BUT "HURT THE FINGER'S SKIN" OF THE NURSE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371812 BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 7241671

    Patients

    Seq Age Sex Outcome Treatment
    1 Other