BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 7359377 · Received March 21, 2018

    Report

    Report Number
    1911916-2018-00117
    Event Type
    Malfunction
    Date Received
    March 21, 2018
    Date of Event
    March 18, 2018
    Report Date
    April 3, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR REVIEW: ALL OUR INSPECTIONS PERFORMED WHILE MANUFACTURING THIS BATCH WERE ACCEPTED; NO REJECTIONS WERE DOCUMENTED. A SAMPLE WAS RECEIVED. IT CAME WITH NO PACKAGING FLOW WRAP AND NO TIP CAP. IT IS WRAPPED IN A TRANSPARENT PLASTIC GLOVE. IT HAS THE PLUNGER ROD-RUBBER STOPPER AND SALINE SOLUTION UP TO THE 3ML MARK. THE BARREL LABEL CONFIRMS THE LOT#7173519. THE SAMPLE DIDN¿T SHOW LEAKAGE PAST STOPPER WHEN TRIED TO SIMULATE THE FAILURE; HOWEVER A 1¿ LONG CRACK ON THE BARREL WALL WAS NOTICED. IT IS TOWARDS THE TOP PART OF THE SYRINGE FROM ABOUT THE 6ML MARK TO THE 10ML MARK. PRODUCT WITHIN SPECIFICATION? ¿ YES ¿ NO INVESTIGATION CONCLUSION: 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 LEAKAGE PAST STOPPER. POSSIBLE ROOT CAUSE IS THE BARREL WALL CRACKED. POSSIBLE THROUGH THE CRACK THE SALINE SOLUTION WENT OVER THE STOPPER WHILE PULLING UP THE PLUNGER ROD-RUBBER STOPPER.

    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 DURING USE A BD POSIFLUSH¿ NORMAL SALINE SYRINGE WAS FOUND LEAKING AS ¿NURSE FOUND LEAKAGE FROM PLUNGER ROD WHEN CARRIED OUT THE EXHAUST OPERATION.¿ THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200680 BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 7173519

    Patients

    Seq Age Sex Outcome Treatment
    1 Other