BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT FILL NEEDLE

    MDR report key: 7104622 · Received December 11, 2017

    Report

    Report Number
    1911916-2017-00342
    Event Type
    Malfunction
    Date Received
    December 11, 2017
    Date of Event
    November 17, 2017
    Report Date
    January 22, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    00382903051809
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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

    INVESTIGATION: ONE SAMPLE WAS RETURNED TO THE COLUMBUS PLANT FOR EVALUATION. IT HAS A PIECE OF BLACK FOREIGN MATTER IN THE PACKAGE THAT APPEARS TO BE A COMBINATION OF LUBE AND DUST THEREFORE FAILURE MODE IS VERIFIED. PROBABLE ROOT CAUSE IS THE FOREIGN MATTER CAME FROM THE ASSEMBLY LINE. THIS IS THE FIRST COMPLAINT WE HAVE HAD FOR THIS DEFECT AND THIS BATCH. THE ASSEMBLIES USED TOTALED 9,580,000. ONE DEFECT FOR FM IS A DEFECT RATE OF .00001%. OUR AQL FOR FM ¿ NON-FLUID PATH IS 1.0%. QN REVIEW: NO NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCH. DHR REVIEW: A DHR REVIEW WAS PERFORMED ON PACKAGED BATCH 7023586, AND ASSEMBLY BATCHES 7024511 AND 7024513. DAILY CLEANING WAS PERFORMED FOUR TIMES, AND WEEKLY CLEANING ONCE DURING THE PACKAGING OF THIS BATCH. DAILY CLEANING WAS PERFORMED 44 TIMES DURING THE ASSEMBLY OF THE NEEDLES. INVESTIGATION RESULTS: ONE SAMPLE WAS RETURNED. IT HAS A PIECE OF BLACK FM IN THE PACKAGE. IT APPEARS TO BE A COMBINATION OF LUBE AND DUST. POSSIBLE ROOT CAUSE: PROBABLE ROOT CAUSE IS THE FM CAME FROM THE ASSEMBLY LINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD¿ BLUNT FILL NEEDLE HAD FOREIGN MATTER IN THE TUBING. FOUND BEFORE USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882884 BD¿ BLUNT FILL NEEDLE MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 7023586 00382903051809

    Patients

    Seq Age Sex Outcome Treatment
    1 Other