BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPS SAFETY NEEDLE

    MDR report key: 13714875 · Received March 9, 2022

    Report

    Report Number
    3017368639-2022-00011
    Event Type
    Malfunction
    Date Received
    March 9, 2022
    Date of Event
    February 10, 2022
    Report Date
    March 9, 2022
    Manufacturer
    WUXI YUSHOU MEDICAL APPLIANCES CO.,LTD.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT WHILE WITHDRAWING VACCINE FROM A PFIZER VIAL, THE NEEDLE DETACHED FROM THE SYRINGE HUB AND REMAINED IN THE DIAPHRAGM OF THE VIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166946 DPS SAFETY NEEDLE 25G X 1" HYPODERMIC SINGLE LUMEN NEEDLE FMI WUXI YUSHOU MEDICAL APPLIANCES CO.,LTD. W2106091

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other