BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 9520888 · Received December 26, 2019

    Report

    Report Number
    1911916-2019-01331
    Event Type
    Malfunction
    Date Received
    December 26, 2019
    Date of Event
    December 10, 2019
    Report Date
    January 20, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051091
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED. 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. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    MATERIAL NO.: 305109, BATCH NO.: 9093857. IT WAS REPORTED THAT DURING USE OF THE BD PRECISIONGLIDE¿ NEEDLE THERE WAS A SMALL HOLE IN THE GREY PLASTIC PART OF THE NEEDLE RESULTING IN LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING A CHILD'S IMMUNIZATION VACCINATION, THE NURSE FOUND THAT THERE WAS A SMALL HOLE IN THE GREY PLASTIC PART OF THE NEEDLE. BY INJECTING THE VACCINE SUBCUTANEOUSLY, THE LIQUID CAME OUT IN THE END JET THROUGH THIS HOLE, RATHER THAN INTO THE CHILD'S ARM.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    MATERIAL NO.: 305109 BATCH NO.: 9093857. IT WAS REPORTED THAT DURING USE OF THE BD PRECISIONGLIDE¿ NEEDLE THERE WAS A SMALL HOLE IN THE GREY PLASTIC PART OF THE NEEDLE RESULTING IN LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING A CHILD'S IMMUNIZATION VACCINATION, THE NURSE FOUND THAT THERE WAS A SMALL HOLE IN THE GREY PLASTIC PART OF THE NEEDLE. BY INJECTING THE VACCINE SUBCUTANEOUSLY, THE LIQUID CAME OUT IN THE END JET THROUGH THIS HOLE, RATHER THAN INTO THE CHILD'S ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316928 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305109 9093857 30382903051091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other