BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    15 DROP PRIMARY SET W/2 BCV-CLAVE

    MDR report key: 2913095 · Received November 28, 2012

    Report

    Report Number
    2913095
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    ICU MEDICAL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    STERILE PACKAGE OPENED IN ANTICIPATION OF IV PREPARATION. CAP WAS REMOVED FROM SPIKE AND NURSE NOTED THAT TIP WAS BLACK. PRODUCT NOT USED ON PATIENT AND NEW PRODUCT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 15 DROP PRIMARY SET W/2 BCV-CLAVE TUBING FPA ICU MEDICAL * 21-564-SJ

    Patients

    Seq Age Sex Outcome Treatment
    1 *