BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 RB

    MDR report key: 21646632 · Received March 19, 2025

    Report

    Report Number
    1911916-2025-00212
    Event Type
    Malfunction
    Date Received
    March 19, 2025
    Date of Event
    March 3, 2025
    Report Date
    March 19, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051961
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: IT WAS REPORTED THERE WAS PARTICULATES OBSERVED INSIDE THE NEEDLE CAPS. TO AID IN THE INVESTIGATION, FOUR SAMPLES AND FIVE PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THREE SAMPLES CAME IN OPENED PACKAGING BLISTERS AND ONE SAMPLE CAME IN A SEALED PACKAGING BLISTER. A VISUAL INSPECTION WAS PERFORMED. ONE SAMPLE HAS A LOOSE PARTICLE OF EPOXY, TWO SAMPLES HAVE AN EPOXY DRIP OVER ON THE NEEDLE HUB AND ONE SAMPLE HAS AN EMBEDDED DARK COLORED SPECK IN THE NEEDLE HUB. THE FIVE PHOTOS PROVIDED SHOW THE SAMPLES RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE EPOXY CONDITION OCCURS IF THERE IS A JAM AT THE CANNULATOR. THE EMBEDDED DEGRADED RESIN IN THE COMPONENT TYPICALLY OCCURS AT THE STARTUP OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305196, LOT 4270137. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS. THE SAMPLES WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION WITH THE RETURNED 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. 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: 305196. BATCH#: 4270137. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. I WORK ON THE XXXX. I AM REACHING OUT TO YOU BECAUSE OUR TEAM RECENTLY RECEIVED A SHIPMENT OF PRECISIONGLIDE NEEDLES (ITEM 305196, BATCH 4270137) WHICH HAVE FAILED INCOMING QUALITY INSPECTION DUE TO THE PRESENCE OF PARTICULATES OBSERVED INSIDE THE NEEDLE CAPS WITHIN THE UNOPENED PACKAGING. DURING INVESTIGATION SAMPLE ANALYSIS ON 17 MARCH 2025. "ONE SAMPLE HAS A LOOSE PARTICLE OF EPOXY,".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641645 NEEDLE 18X1-1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4270137 30382903051961

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown