BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRADIS

    MDR report key: 13659282 · Received March 3, 2022

    Report

    Report Number
    13659282
    Event Type
    Malfunction
    Date Received
    March 3, 2022
    Date of Event
    February 3, 2022
    Report Date
    February 7, 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 KIT WAS NOT SET UP PROPERLY AND DID NOT INCLUDE GLOVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287920 STRADIS GENERAL SURGERY TRAY LRO STRADIS HEALTHCARE HCT541BP-2 220040148

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown