BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE

    MDR report key: 12000836 · Received June 15, 2021

    Report

    Report Number
    1911916-2021-00556
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    May 18, 2021
    Report Date
    May 20, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051251
    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

    INVESTIGATION SUMMARY: IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE GLUE THAT HOLDS THE NEEDLE TO THE PLASTIC HAS LEAKED. TO AID IN THE INVESTIGATION, ONE PHOTO WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A NEEDLE ASSEMBLY WITH NO PACKAGING BLISTER OR PLASTIC SHIELD. IT HAS WHITE EPOXY DRIP OVER ON THE NEEDLE. THIS DEFECT CAN OCCUR DURING THE ASSEMBLY PROCESS. THE PLASTIC HUB IS PLACED UNDER THE CANNULATOR, THEN THE NEEDLE IS POSITIONED AND ASSEMBLED TO THE PLASTIC HUB ADDING THE WHITE EPOXY TO FIX IT. AFTER, A PLASTIC SHIELD IS ASSEMBLED. IN THIS CASE, THE MISFEEDING OF THE CANNULATOR MAY HAVE INDUCED THE EPOXY ON THE NEEDLE HUB. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305125, LOT 0022982. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. VERIFICATION OF THE CANNULATOR SETTINGS AND PRODUCT FLOW WAS PERFORMED FINDING EVERYTHING CORRECT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EPOXY HOLDING THE BD PRECISIONGLIDE¿ NEEDLE TO THE HUB LEAKED OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE A DEFECTIVE SYRINGE NEEDLE. IT APPEARS THAT THE GLUE THAT HOLDS THE NEEDLE TO THE PLASTIC HAS LEAKED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900009 BD PRECISIONGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305125 0022982 30382903051251

    Patients

    Seq Age Sex Outcome Treatment
    1