BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TKMD

    MDR report key: 13714846 · Received March 9, 2022

    Report

    Report Number
    3017368639-2022-00010
    Event Type
    Malfunction
    Date Received
    March 9, 2022
    Date of Event
    February 9, 2022
    Report Date
    March 9, 2022
    Manufacturer
    ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MCKESSON MEDICAL-SURGICAL, INC. IS THE ASSEMBLER OF CONVENIENCE KITS THAT CAN CONTAIN A SYRINGE 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 ON (B)(6) 2022, UPON INSPECTING THE SYRINGES, MOLD AND CONDENSATION WERE DISCOVERED INSIDE THE SEALED, PACKAGED SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167933 TKMD PISTON SYRINGE FMF ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD. TKSLL-001 20210401

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other