BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ SYRINGE

    MDR report key: 7342146 · Received March 15, 2018

    Report

    Report Number
    1911916-2018-00077
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    February 22, 2018
    Report Date
    February 26, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. INVESTIGATION: TWO PHOTO SAMPLES WERE AVAILABLE FOR EVALUATION FOR THE (B)(4) MANUFACTURING PLANT. A QUALITY ENGINEER REVIEWED THE IMAGES AND DETERMINED THAT ONE OF THE SYRINGES HAD A DAMAGED BARREL AND THE OTHER HAD A DAMAGED BARREL FLANGE. BASED OFF OF THE PHOTOS THE ENGINEER WAS ABLE TO VERIFY THE FAILURE MODE. THERE WERE NO QUALITY ISSUES FOUND DURING THE PRODUCTION OF THIS BATCH AND THE ROOT CAUSE COULD HAVE BEEN THE PLUNGER ROD LABELER EQUIPMENT. THE EQUIPMENT HAS BEEN VERIFIED AND THE ADJUSTMENTS OF THE INFEED SCROLL AND REJECT STATIONS ARE CORRECT. A DHR WAS PERFORMED AND NO DOCUMENTATION ISSUES WERE FOUND FOR BARREL/FLANGE DAMAGE FOR THIS BATCH. DHR/BHR REVIEW THERE WAS NO DOCUMENTATION ISSUES FOR BARREL/ FLANGE DAMAGE FOR THE COMPLAINT OF BATCH 7159647 DURING THIS PRODUCTION RUN. INVESTIGATION COMMENTS: ALL OUR INSPECTIONS PERFORMED WHILE MANUFACTURING THIS BATCH WERE ACCEPTED. NO REJECTIONS WERE DOCUMENTED. ON (B)(6) 2018 TWO PHOTOS WERE RECEIVED. PHOTO 1: IT SHOWS A SYRINGE WITH PLUNGER ROD-STOPPER AND SALINE IN IT. IT IS WITH NO PACKAGING FLOW WRAP. IT IS NOT POSSIBLE TO CONFIRM THE CATALOG NUMBER AND LOT NUMBER. IT HAS THE BARREL DAMAGED. PHOTO2. IT SHOWS A SYRINGE WITH NO PACKAGING FLOW WRAP. IT HAS THE PLUNGER ROD-RUBBER STOPPER AND SALINE SOLUTION. THE BARREL LABEL HAS THE LOT# 7230998. IT HAS 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 WERE NO PARTS DAMAGED DOCUMENTED. UPDATE. MAR 01, 2018. FROM THE PHOTOS PROVIDED AND ANALYZING OTHER SAMPLES RECEIVED FROM DIFFERENT COMPLAINTS IT COULD POSSIBLY BE THAT THIS FLANGE DAMAGED WAS CAUSED AT THE PLUNGER ROD LABELER EQUIPMENT. THE EQUIPMENT HAS BEEN VERIFIED THAT ADJUSTMENTS OF THE INFEED SCROLL AND THE REJECT STATIONS ARE CORRECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FLANGE OF A BD POSIFLUSH¿ SYRINGE WAS DAMAGED. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184471 BD POSIFLUSH¿ SYRINGE FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 7159647

    Patients

    Seq Age Sex Outcome Treatment
    1 Other