BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE

    MDR report key: 7189191 · Received January 15, 2018

    Report

    Report Number
    1911916-2017-00405
    Event Type
    Malfunction
    Date Received
    January 15, 2018
    Date of Event
    December 19, 2017
    Report Date
    January 25, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    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

    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 A SAMPLE WERE RECEIVED IN THE COLUMBUS PLANT FOR EVALUATION. FROM THE PHOTO IT IS NOT CLEAR THE FOREIGN MATTER. A PHYSICAL SAMPLE WAS RECEIVED IN THE COLUMBUS PLANT FOR EVALUATION. THE BARREL LABEL CONFIRMS THE LOT# 7051641. THE VISUAL INSPECTIONS VERIFIES A FOREIGN MATTER IN THE SALINE SOLUTION. THE PLUNGER ROD- RUBBER STOPPER WAS TAKEN OUT OF THE BARREL, AND A PIECE OF PLASTIC WAS REMOVED. THIS IS A PIECE OF A PLASTIC THAT HAS THE BARREL FLANGE AND ABOUT 1/8¿ OF A BARREL WALL. PART OF THE BARREL FLANGE IS BENT TOWARDS THE BARREL WALL; THE SECTION BELONGING TO A BARREL WALL HAS IRREGULAR SHAPE AND SHOWS INDENTIONS. THE ACTUAL SYRINGE HAS NO DAMAGES IN ANY AREA. MOST PROBABLE ROOT CAUSE IS THAT THIS PIECE OF PLASTIC COULD HAVE FALLEN INTO THE SYRINGE AT THE FILL MACHINE; POSSIBLE A JAM HAPPENED, DAMAGING A BARREL AND THIS PIECE OF PLASTIC FLEW FALLING INTO THIS SYRINGE. THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH 7051641 DURING THIS PRODUCTION RUN. THE PIECE OF PLASTIC COULD HAVE FALLEN INTO THE SYRINGE AT THE FILL MACHINE; POSSIBLE A JAM HAPPENED, DAMAGING A BARREL AND THIS PIECE OF PLASTIC FLEW FALLING INTO THIS SYRINGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NURSE FOUND FOREIGN MATTER IN THE SALINE OF THE BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE. FOUND BEFORE USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36047 BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE PREFILLED SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 7051641

    Patients

    Seq Age Sex Outcome Treatment
    1 Other