BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPS

    MDR report key: 17455205 · Received August 3, 2023

    Report

    Report Number
    3017368639-2023-00009
    Event Type
    Malfunction
    Date Received
    August 3, 2023
    Date of Event
    July 5, 2023
    Report Date
    July 25, 2023
    Manufacturer
    DUOPROSS MEDITECH CORPORATION
    Product Code
    FMI
    UDI-DI
    06971352289020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MCKESSON MEDICAL-SURGICAL, INC. IS THE ASSEMBLER OF CONVENIENCE KITS THAT COULD CONTAIN THE DEVICE FROM THE MANUFACTURER IDENTIFIED IN SECTION D. THE ITEM REF # AND LOT # REPORTED AND IDENTIFIED IN SECTION D HAVE BEEN CONFIRMED AS HAVING BEEN USED IN THE ASSEMBLY OF CONVENIENCE KITS SUPPLIED BY MCKESSON MEDICAL-SURGICAL, INC. WE HAVE NOTIFIED USARMY (B)(6) FOR AWARENESS.

    Description of Event or Problem · 0

    COMPLAINANT REPORTED MULTIPLE NEEDLESTICK EVENTS WHERE THE SAFETY SHIELDS ON THE ORANGE 25GX1" NEEDLE COMPLETELY FALLS OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283990 DPS 25G X 1" HYPODERMIC SAFETY NEEDLE WITHOUT SYRINGE FMI DUOPROSS MEDITECH CORPORATION 25G×1'' (0.5×25) W2105094 06971352289020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown