BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUR SET

    MDR report key: 11378101 · Received February 25, 2021

    Report

    Report Number
    11378101
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Date of Event
    February 4, 2021
    Report Date
    February 19, 2021
    Manufacturer
    ICU MEDICAL FLEET SERVICES, LLC
    Product Code
    GBX
    UDI-DI
    10887709101873
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHEN OPENING AN ICU MEDICAL LATEX-FREE T-U-R Y-SET NON VENTED SET FOR TRANSURETHRAL RESECTION PROCEDURES 96 INCH, A HAIR WAS FOUND INSIDE THE PACKAGING WITH THE TUBING PRODUCT. AS THIS IS A FACTORY SEALED PRODUCT, IT CAME FROM THE MANUFACTURER THIS WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274126 TUR SET CATHETER, IRRIGATION GBX ICU MEDICAL FLEET SERVICES, LLC 654301 4902592 10887709101873

    Patients

    Seq Age Sex Outcome Treatment
    1 7300 DA