BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPS

    MDR report key: 16431846 · Received February 23, 2023

    Report

    Report Number
    3017368639-2023-00001
    Event Type
    Malfunction
    Date Received
    February 23, 2023
    Date of Event
    January 25, 2023
    Report Date
    February 13, 2023
    Manufacturer
    WUXI YUSHOU MEDICAL APPLIANCES CO.,LTD.
    Product Code
    FMI
    UDI-DI
    06971352289020
    PMA / PMN Number
    K130212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 CAN 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. THE DEVICE MANUFACTURER PRINTED ON THE PRODUCT PACKAGING IS IDENTIFIED IN SECTION D, AND THE DEVICE DISTRIBUTOR PRINTED ON THE PACKAGING IS DUOPROSS MEDITECH CORPORATION (REFER TO DUOPROSS.COM FOR ADDITIONAL INFORMATION). WE HAVE NOTIFIED [email protected] AND [email protected] FOR AWARENESS.

    Description of Event or Problem · 0

    THE NURSE WHO ADMINISTERED THE COVID-19 VACCINE REPORTED THAT SHE FACED ISSUES WHILE USING THE 25G, 1" DPS SAFETY NEEDLE. THE NEEDLE POINT WAS NOT SHARP; IT WAS BLUNT. THE COMMON ISSUE OCCURRED WHEN VACCINATING A PATIENT. THE NEEDLE PENETRATION REQUIRED EXTRA FORCE, AND FEEDBACK WAS RECEIVED FROM THE PATIENT THAT THE EXPERIENCE WAS PAINFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444536 DPS 25G X 1" SAFETY NEEDLE WITHOUT SYRINGE FMI WUXI YUSHOU MEDICAL APPLIANCES CO.,LTD. 25G X 1" 2012057 06971352289020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown