BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 12149130 · Received July 12, 2021

    Report

    Report Number
    12149130
    Event Type
    Malfunction
    Date Received
    July 12, 2021
    Date of Event
    June 29, 2021
    Report Date
    June 30, 2021
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    MPN
    UDI-DI
    10885380101588
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH HISTORY OF ENDOMETRIAL CANCER WAS ADMITTED FOR A RIGHT CHEST PORT PLACEMENT. WHEN OPENING THE CARDINAL HEALTH 200, LLC OCTYL TOPICAL SKIN ADHESIVE, DOME TIP, 0.8ML, THE SKIN GLUE WOULD NOT OPEN. NO GLUE WOULD COME OUT. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046593 CARDINAL HEALTH TISSUE ADHESIVE FOR THE TOPICAL APPROXIMATION OF SKIN MPN CARDINAL HEALTH 200, LLC CHLOT01-08 P00221356 10885380101588

    Patients

    Seq Age Sex Outcome Treatment
    1 17885 DA