BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ 18 G X 1-1/2" HYPODERMIC NEEDLES

    MDR report key: 13283146 · Received January 18, 2022

    Report

    Report Number
    1911916-2022-00003
    Event Type
    Malfunction
    Date Received
    January 18, 2022
    Date of Event
    December 22, 2021
    Report Date
    January 4, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051961
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT. INVESTIGATION SUMMARY: IT WAS REPORTED THERE WAS A BLUNT, CHIPPED END ON THE NEEDLE TIP THAT WAS CORING AN UNUSUALLY LARGE AMOUNT OF VIAL STOPPERS. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. ONE PHOTO SHOWS THE PACKAGING BLISTER TOP WEBS. THE OTHER PHOTO SHOWS TWO NEEDLES. ONE IS GOOD FOR COMPARISON AND THE OTHER HAS A NEEDLE TIP WITH DEFECTIVE GRINDING. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305196, LOT NUMBER 1210807. 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 GRINDING PROCESS WAS PERFORMED. SETTINGS WERE CORRECT, PRODUCTS WERE BEING PLACED CORRECTLY AND THE FLOW OF PRODUCT WAS GOOD. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. 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 · 0

    IT WAS REPORTED THAT BD PRECISIONGLIDE¿ 18 G X 1-1/2" HYPODERMIC NEEDLES CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " OUR PHARMACY TECHNICIAN WORKING IN THE IV ROOM TODAY NOTICED THAT SEVERAL 18G 1 ½¿? NEEDLES THAT WERE MALFORMED ON THE END. SHE NOTED THIS BECAUSE SHE WAS CORING AN UNUSUALLY LARGE AMOUNT OF VIAL STOPPERS WHILE MAKING IVS. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035045 BD PRECISIONGLIDE¿ 18 G X 1-1/2" HYPODERMIC NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305196 1210807 30382903051961

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown