BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL PRESOURCE

    MDR report key: 6650448 · Received June 19, 2017

    Report

    Report Number
    6650448
    Event Type
    Malfunction
    Date Received
    June 19, 2017
    Date of Event
    June 6, 2017
    Report Date
    June 15, 2017
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FNY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING SETUP OF AN OPERATING ROOM (OR) PROCEDURE, THE NURSE/SCRUB TECH OPENED A MAJOR BASIN SET-UP PACK. THE BACK TABLE COVER WAS REMOVED TO DRAPE ON THE TABLE. THE DRAPE WAS STUCK TO ITSELF AND WOULD NOT UNFOLD PROPERLY. ADDITIONALLY THERE WAS A HOLE IN THE DRAPE, POSSIBLY FROM TRYING TO OPEN THE DRAPE. ANOTHER PACK WAS USED WITHOUT INCIDENT. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430256 CARDINAL PRESOURCE STERILE MAJOR BASIN PACK FNY CARDINAL HEALTH SUT21MBARD 691768

    Patients

    Seq Age Sex Outcome Treatment
    1