BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACK CV BYPASS DRMC

    MDR report key: 6046863 · Received October 21, 2016

    Report

    Report Number
    6046863
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Date of Event
    October 5, 2016
    Report Date
    October 6, 2016
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    KDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A HAIR WAS FOUND IN THE CV PACK UPON OPENING IT PRIOR TO MULTIPLE PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697942 PACK CV BYPASS DRMC PACK CV BYPASS DRMC KDD CARDINAL HEALTH 200, LLC SCV56BPDMS 528520

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR