BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2133390 · Received June 13, 2011

    Report

    Report Number
    2133390
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 13, 2011
    Manufacturer
    CARDINAL HEALTH
    Product Code
    LRP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE STERILE VENOUS ACCESS PACK WAS OPENED IN PREPARATION FOR INSERTING A PICC CATHETER. THE TECH PREPARING THE TRAY, DONNED IN APPROPRIATE HEAD COVERING, NOTICED A HAIR UNDER THE GAUZE SPONGES. THE TRAY WAS IMMEDIATELY REMOVED FROM THE PROCEDURE ROOM AND ANOTHER TRAY WAS PREPPED. THE HAIR WAS DISCOVERED PRIOR TO THE PATIENT ENTERING THE PROCEDURAL SUITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PACK, STERILE, SURGICAL LRP CARDINAL HEALTH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *