BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHIFENG

    MDR report key: 15781234 · Received November 11, 2022

    Report

    Report Number
    3017368639-2022-00032
    Event Type
    Malfunction
    Date Received
    November 11, 2022
    Date of Event
    October 18, 2022
    Report Date
    October 28, 2022
    Manufacturer
    CHENGDU XINJIN SHIFENG MEDICAL
    Product Code
    FMI
    UDI-DI
    G001N25100
    PMA / PMN Number
    K142765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THE ISSUE WAS WITH THE SHIFENG PRODUCT SUPPLIED IN THE KIT, INDICATING THAT THE SAFETY DOESN'T ALWAYS LATCH RIGHT AWAY. IT TAKES MORE PRESSURE TO GET THE SAFETY TO ENGAGE. CUSTOMER PROVIDED MFR# N-2510 AND LOT # 210307 AS ADDITIONAL PRODUCT IDENTIFICATION INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2830564 SHIFENG 25G SHIFENG SAFETY NEEDLE FMI CHENGDU XINJIN SHIFENG MEDICAL N-2510 210307 G001N25100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown