BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ SYRINGE

    MDR report key: 7355746 · Received March 20, 2018

    Report

    Report Number
    1911916-2018-00113
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    March 14, 2018
    Report Date
    March 27, 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 · 1

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

    Additional Manufacturer Narrative · 1

    A PHOTO AND SAMPLE WERE AVAILABLE FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PHOTO AND SAMPLE AND FOUND THAT THERE WAS BARREL/FLANGE DAMAGE IN BOTH THUS VERIFYING THE REPORTED ISSUE. A POSSIBLE ROOT CAUSE WAS DETERMINED TO HAVE BEEN A VARIATION WITH THE PLUNGER ROD LABELER. THE EQUIPMENT WAS INSPECTED AND ANY NECESSARY ADJUSTMENTS WERE MADE. THERE WERE NO QUALITY NOTIFICATIONS FOUND DURING PRODUCTION OF THE REPORTED BATCH. THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH 7230502 DURING THIS PRODUCTION RUN. ROOT CAUSE COULD NOT BE DETERMINED. IT IS POSSIBLE THE PLUNGER ROD LABELER EQUIPMENT EXPERIENCED A VARIATION; HOWEVER, ADJUSTMENTS HAVE BEEN VERIFIED. CAPA NOT REQUIRED FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE A BD POSIFLUSH¿ SYRINGE WAS FOUND DAMAGED AS ¿NURSE FOUND FLANGE DAMAGED AFTER OPENED PLASTIC PACKAGE.¿ THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194824 BD POSIFLUSH¿ SYRINGE SALINE FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 7230502

    Patients

    Seq Age Sex Outcome Treatment
    1 Other