BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE

    MDR report key: 11829663 · Received May 15, 2021

    Report

    Report Number
    1911916-2021-00451
    Event Type
    Malfunction
    Date Received
    May 15, 2021
    Date of Event
    April 17, 2021
    Report Date
    April 21, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: IT WAS REPORTED THERE WERE TWO DIFFERENT SIZES OF NEEDLES IN THE SAME STRIP. TO AID IN THE INVESTIGATION, A SET OF FIVE SAMPLES AND ONE PHOTO WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLES CAME IN SEALED PACKAGING BLISTERS. A VISUAL INSPECTION WAS PERFORMED. ONE SAMPLE HAS A 1" NEEDLE AND THE REST ARE 1/2" NEEDLES. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE PHOTO PROVIDED SHOWS THE SAMPLES RECEIVED. THIS DEFECT CAN OCCUR DURING LINE CLEARANCE WHEN CHANGING PRODUCTION ORDERS THE LINE CLEARANCE WAS NOT PROPERLY DONE LEAVING THIS UNIT IN THE FEEDER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305106, LOT NUMBER 9193522. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. A REVIEWER TO THE LINE CLEARANCE WAS ADDED TO MITIGATE THESE ESCAPES. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD PRECISIONGLIDE¿ NEEDLE THERE WAS MIX OF PRODUCT TYPES IN A PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WERE "TWO DIFFERENT SIZES OF NEEDLES IN THE SAME STRIP." VERBATIM: WE FOUND TWO DIFFERENT SIZES OF NEEDLES IN THE SAME STRIP. STRIP WAS FOR BD PRECISION GLIDE 30G 1/2 NEEDLES, BUT ALSO HAD 30G 1 AND HALF NEEDLES PACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726159 BD PRECISIONGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305106 9193522 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1