BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 13051611 · Received December 21, 2021

    Report

    Report Number
    13051611
    Event Type
    Malfunction
    Date Received
    December 21, 2021
    Date of Event
    November 28, 2021
    Report Date
    December 15, 2021
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    OXQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CENTRAL LINE DRESSING CHANGE KIT (LOT #649934). ALCOHOL SWAB PACKAGES ARE FALLING APART WHEN YOU USE THEM ON A PATIENT. THEY HAVE LEFT LITTLE PIECES OF GAUZE ON THE STITCHES, AS THEY CATCH WHEN CLEANING THE LINE. THIS IS NOT SAFE FOR PATIENTS AND NOT AN EFFECTIVE SWAB TO CLEAN A LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1955442 CARDINAL HEALTH DRESSING CHANGE TRAY OXQ CARDINAL HEALTH 200, LLC 03B8920B 649934

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown