BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE

    MDR report key: 11891533 · Received May 26, 2021

    Report

    Report Number
    1911916-2021-00484
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    April 27, 2021
    Report Date
    May 18, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: IT WAS REPORTED THERE WAS FOREIGN MATTER FOUND ON THE NEEDLE PART. TO AID IN THE INVESTIGATION, TWO SAMPLES WITH THE PLASTIC SHIELD AND ONE PHOTO WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED WITH A 30X MICROSCOPE. ONE SAMPLE HAS NO DEFECTS OR IMPERFECTIONS; THE OTHER SAMPLE HAS AN EPOXY DRIP OVER ON THE NEEDLE. THE PHOTO PROVIDED SHOWS THE SAMPLE RECEIVED WITH THE EPOXY DRIP OVER. THIS DEFECT CAN OCCUR DURING THE ASSEMBLY PROCESS. DURING MANUFACTURING, 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. IN THIS CASE, THE MISFEEDING OF THE CANNULATOR MAY HAVE INDUCED THE EPOXY ON THE NEEDLE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305107, LOT NUMBER 0022947. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE AND 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 2 BD PRECISIONGLIDE¿ NEEDLES HAD FOREIGN MATTER ON THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FOUND FOREIGN MATERIAL ON NEEDLE PART."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786809 BD PRECISIONGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 0022947

    Patients

    Seq Age Sex Outcome Treatment
    1