BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT CAP CHANGE STERILE

    MDR report key: 21833829 · Received April 14, 2025

    Report

    Report Number
    MW5168981
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Date of Event
    April 7, 2025
    Report Date
    April 8, 2025
    Manufacturer
    TRINITY STERILE, INC.
    Product Code
    OXQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE PREPARING TO DO A CAP CHANGE, A CAP CHANGE TRAY WAS OPENED IN A STERILE MANOR. A HAIR WAS FOUND WITHIN THE PACKAGING. A NEW KIT WAS OBTAINED AND CAP CHANGE WAS COMPLETE. PACKAGE INFORMATION: GTIN: (B)(4); EXP (17) 2025-06-01; LOT (10) 6000625.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2270313 KIT CAP CHANGE STERILE DRESSING CHANGE TRAY OXQ TRINITY STERILE, INC. (10)6000625

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown