BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ SYRINGE

    MDR report key: 7484452 · Received May 3, 2018

    Report

    Report Number
    1911916-2018-00216
    Event Type
    Malfunction
    Date Received
    May 3, 2018
    Date of Event
    April 9, 2018
    Report Date
    May 16, 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

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THREE SAMPLES WERE RECEIVED FOR EVALUATION. THEY ARE WITH NO PACKAGING FLOW WRAP. THEY ALL HAVE THE PLUNGER ROD, THE RUBBER STOPPER, THE TIP CAP AND SALINE SOLUTION. THE BARREL LABELS CONFIRM THE LOT#7230501. THE PLUNGER ROD OF THE THREE SYRINGES ARE DAMAGED THEREFORE FAILURE MODE IS VERIFIED. 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. A DEVICE HISTORY REVIEW WAS COMPLETED WITH NO ISSUES DOCUMENTED DURING THE PRODUCTION OF THIS BATCH FOR ANY DAMAGE OR BROKEN PLUNGER RODS. THE TYPE OF DAMAGE THE PLUNGER RODS HAVE IS FROM A PROCESS VARIATION OF THE FLOW WRAPPER MACHINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLUNGER ROD OF A BD POSIFLUSH¿ SYRINGE WAS BROKEN, BEFORE USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325085 BD POSIFLUSH¿ SYRINGE FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 7230501

    Patients

    Seq Age Sex Outcome Treatment
    1 Other