BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1911916-2018-00594

    MDR report key: 8010962 · Received October 26, 2018

    Report

    Report Number
    1911916-2018-00594
    Event Type
    Malfunction
    Date Received
    October 26, 2018
    Date of Event
    October 5, 2018
    Report Date
    October 19, 2018
    PMA / PMN Number
    K141311
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: EIGHT SAMPLES WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED. THE SAMPLES HAVE SEALED THE PACKAGING FLOW WRAP, PLUNGER ROD-RUBBER STOPPER, TIP CAP, SALINE SOLUTION AND THE BARREL LABELS CONFIRMS THE LOT# 8142702. SYRINGE IS NOT INTENDED TO DRAW BLOOD AND IS FOR SINGLE USE. NONE OF THE SAMPLES HAVE A SEPARATION BETWEEN THE PLUNGER ROD AND THE RUBBER STOPPER THEREFORE FAILURE MODE IS NOT VERIFIED. THE SYRINGE IS NOT INTENDED TO BE USED TO DRAW BLOOD AND IS FOR SINGLE USE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: THIS IS THE FIRST COMPLAINT FOR LOT # 8142702 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: NOT CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD POSIFLUSH¿ NS FILLED SYRINGES HAVE PLUNGERS THAT WILL POP BACK AND THEN CANNOT BE PULLED BACK ANYMORE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other