BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRAL LINE KIT

    MDR report key: 13860476 · Received March 23, 2022

    Report

    Report Number
    13860476
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    March 7, 2022
    Report Date
    March 10, 2022
    Manufacturer
    STRADIS HEALTHCARE
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    CENTRAL LINE KITS ARE MISSING CLAVES. MULTIPLE KITS HAVE BEEN IDENTIFIED AND PULLED FROM CIRCULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562104 CENTRAL LINE KIT GENERAL SURGERY TRAY LRO STRADIS HEALTHCARE 211112719

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown