BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ NEEDLE 1 IN. SINGLE USE, STERILE, 18 G

    MDR report key: 13801015 · Received March 17, 2022

    Report

    Report Number
    1911916-2022-00142
    Event Type
    Malfunction
    Date Received
    March 17, 2022
    Date of Event
    February 24, 2022
    Report Date
    March 9, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051954
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THE NEEDLE SEPARATED FROM THE HUB. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A SYRINGE WITH A PLASTIC NEEDLE HUB, A VIAL WITH A NEEDLE INSERTED IN IT AND AN OPENED PACKAGING BLISTER. THE BOTTOM PART OF THE NEEDLE IS OUT OF THE VIAL AND HAS NO RESIDUES OF WHITE EPOXY. THE NEEDLE HUB ALSO HAS NO RESIDUES OF WHITE EPOXY. THIS DEFECT COULD 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. AFTER, A PLASTIC SHIELD IS ASSEMBLED. IN THIS CASE, A JAM MAY HAVE OCCURRED AT THE CANNULATOR INDUCING THE LACK OR NOT ENOUGH EPOXY APPLIED TO THE PRODUCT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305195, LOT NUMBER 1210325. 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 WAS PERFORMED. THE SETTINGS WERE CORRECT AND THE FLOW OF PRODUCTS 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 WHILE USING A BD¿ NEEDLE 1 IN. SINGLE USE, STERILE, 18 G, THE NEEDLE PULLED OUT OF HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE DRAWING UP FROM THE VIAL, THE 18 G NEEDLE SHAFT CAME OUT OF THE NEEDLE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695854 BD¿ NEEDLE 1 IN. SINGLE USE, STERILE, 18 G HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305195 1210325 30382903051954

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown