BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ NEEDLE NS 27GA 1IN BLT SQ GRD W/O SHLD

    MDR report key: 8073674 · Received November 15, 2018

    Report

    Report Number
    1911916-2018-00638
    Event Type
    Malfunction
    Date Received
    November 15, 2018
    Date of Event
    October 25, 2018
    Report Date
    January 28, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWO PHOTOS WERE PROVIDED FOR EVALUATION. ONE PHOTO SHOWS ONE NEEDLE ASSEMBLY WITH ORANGE HUB IN THE MIDDLE OF NEEDLE ASSEMBLIES WITH GRAY HUB. THE 2ND PHOTO SHOWS ABOVE DESCRIBED CONDITION WITH A PLASTIC ZIPLOC BAG WITH A GREEN COLOR ID LABEL WHICH HAS THE FOLLOWING INFORMATION: ¿ ITEM 05-0020, LOT# 201003130078, RECEIVING DATE 03/13/18, UPPER LEFT CORNER HAND WRITTEN: #3, BOTTOM RIGHT SIDE HAND WRITTEN: 4/20¿. FAILURE MODE IS VERIFIED. ROOT CAUSE COULD NOT BE DETERMINED AS NO ISSUES SHOWED UP IN THE DEVICE HISTORY RECORD REVIEW AND NO QUALITY NOTIFICATIONS WERE ISSUED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ORANGE BLUNT CANNULA WAS MIXED IN WITH THE BD¿ NEEDLES NS 27GA 1IN BLT SQ GRD W/O SHLD. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: N/A. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ORANGE BLUNT CANNULA WAS MIXED IN WITH THE BD¿ NEEDLES NS 27GA 1IN BLT SQ GRD W/O SHLD. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916367 BD¿ NEEDLE NS 27GA 1IN BLT SQ GRD W/O SHLD HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 7136617

    Patients

    Seq Age Sex Outcome Treatment
    1 Other