BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 8864231 · Received August 6, 2019

    Report

    Report Number
    8864231
    Event Type
    Malfunction
    Date Received
    August 6, 2019
    Date of Event
    July 10, 2019
    Report Date
    July 19, 2019
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    NWU
    UDI-DI
    10888439446616
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CAREGIVER OPENED THE CYSTO PACK FOR A CASE AND SAW A PIECE OF SOMETHING ON THE PACK. IT WAS SEEN RIGHT AWAY AND NOTHING ELSE WAS CONTAMINATED. THERE WAS NO HARM CAME TO THE PATIENT. IT LOOKED LIKE A CRUMB OR A SMALL ROCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660213 CARDINAL HEALTH ENDOSCOPE INTRODUCER KIT NWU CARDINAL HEALTH 200, LLC SBA56PUIMB 216990 10888439446616

    Patients

    Seq Age Sex Outcome Treatment
    1