BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMITHS- MEDICAL HYPODERMIC NEEDLE-PRO EDGE

    MDR report key: 12546697 · Received September 28, 2021

    Report

    Report Number
    MW5104245
    Event Type
    Malfunction
    Date Received
    September 28, 2021
    Date of Event
    September 14, 2021
    Report Date
    September 27, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TWO (2) NEEDLES RECEIVED BY THE (B)(6) HEALTH DEPARTMENT IN COVID-19 ANCILLARY KITS WERE FOUND TO BE BENT UPON OPENING THE PACKAGE. THE (B)(6) HEALTH DEPARTMENT ALSO REPORTS 1 INCIDENT OF THE SAME PRODUCT WITH THE NEEDLE BENDING WHEN REPLACE THE CAP AFTER DRAWING UP COVID-19 VACCINE AND PUNCTURING THE NEEDLE CAP. SMITHS- MEDICAL HYPODERMIC NEEDLE-PRO EDGE, LOT NUMBER 4132535. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1442100 SMITHS- MEDICAL HYPODERMIC NEEDLE-PRO EDGE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI SMITHS MEDICAL ASD, INC. 10014826-002 4132535
    1442101 SMITHS- MEDICAL HYPODERMIC NEEDLE-PRO EDGE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI SMITHS MEDICAL ASD, INC. 10014826-002 4132535
    1442102 SMITHS- MEDICAL HYPODERMIC NEEDLE-PRO EDGE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI SMITHS MEDICAL ASD, INC. 10014826-002 4132535

    Patients

    Seq Age Sex Outcome Treatment
    1