BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE

    MDR report key: 23710774 · Received December 3, 2025

    Report

    Report Number
    1911916-2025-00776
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Date of Event
    November 12, 2025
    Report Date
    November 17, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    00382903051977
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT EXCESS WHITE ADHESIVE WAS PRESENT ON THE HUB WHERE THE NEEDLE AND HUB MEET. TO SUPPORT THE INVESTIGATION, FIVE PHOTOGRAPHS WERE PROVIDED FOR EVALUATION BY THE QUALITY TEAM. ONE IMAGE SHOWS THE PACKAGING BLISTER TOP WEB, ANOTHER DEPICTS A NEEDLE ASSEMBLY WITHOUT A PACKAGING BLISTER OR PLASTIC SHIELD, AND THE REMAINING THREE DISPLAY TWO NEEDLE ASSEMBLIES WITH PLASTIC SHIELDS BUT WITHOUT PACKAGING BLISTERS, ALONG WITH VISIBLE EPOXY OVERFLOW ON THE NEEDLE HUB. NO ADDITIONAL DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS CONDITION MAY OCCUR IF A JAM OCCURS AT THE CANNULATOR. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR MATERIAL NUMBER: 305197, LOT: 5091510. THE REVIEW CONFIRMED THAT NO QUALITY ISSUES WERE DETECTED DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS, AND ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. VERIFICATION OF THE CANNULATOR SETTINGS WAS PERFORMED, CONFIRMING THAT THE SETTINGS WERE CORRECT AND PRODUCT FLOW WAS NORMAL. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND ANALYSIS OF THE PHOTO SAMPLES, THE CUSTOMER¿S REPORTED OBSERVATION HAS BEEN CONFIRMED. 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

    IT WAS REPORTED THAT THE BD NEEDLE 16X1 RB HAD EXCESSIVE EPOXY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA PHONE. THE WHITE GLUE WHERE THE HUB AND NEEDLE MEET IS ALL OVER THE HUB OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2854508 BD PRECISIONGLIDE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 5091510 00382903051977

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown