BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT FILL NEEDLE

    MDR report key: 7129817 · Received December 19, 2017

    Report

    Report Number
    1911916-2017-00373
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    November 15, 2017
    Report Date
    January 31, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903051800
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE SAMPLE WAS RETURNED TO THE (B)(4) PLANT FOR EVALUATION. IT HAS A PIECE OF BLACK FOREIGN MATTER ON THE HUB 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. 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 6363511. DAILY CLEANING WAS PERFORMED FOUR TIMES, AND WEEKLY CLEANING ONCE DURING THE PACKAGING OF THIS BATCH. DAILY CLEANING WAS PERFORMED 37 TIMES DURING THE ASSEMBLY OF THE NEEDLES. INVESTIGATION CONCLUSION: PROBABLE ROOT CAUSE IS THE FM CAME FROM THE ASSEMBLY LINE. IF CORRECTIVE/PREVENTATIVE ACTION NOT REQUIRED, PROVIDE RATIONALE: THIS IS THE FIRST COMPLAINT WE HAVE HAD FOR THIS DEFECT AND THIS BATCH. THE ASSEMBLIES USED TOTALED (B)(4). ONE DEFECT FOR FM IS A DEFECT RATE OF (B)(4). OUR AQL FOR FM ¿ NON-FLUID PATH IS (B)(4). ALTHOUGH THE FM DOES NOT MEET OUR SPECIFICATION, NEITHER DOES IT EXCEED OUR AQL FOR FM. NO CAPA WILL BE INITIATED AT THIS POINT.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (B)(6). INITIAL REPORTER FAX #: (B)(6). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE OUTSIDE OF THE NEEDLE OF THE BD¿ BLUNT FILL NEEDLE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911737 BD¿ BLUNT FILL NEEDLE BLUNT NEEDLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 7023566 30382903051800

    Patients

    Seq Age Sex Outcome Treatment
    1 Other