BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1071445 · Received July 1, 2008

    Report

    Report Number
    1071445
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    June 17, 2008
    Report Date
    June 24, 2008
    Manufacturer
    HOSPIRA GLOBAL MEDICAL AFFAIRS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ATTENDING PHYSICIAN INSERTED A PERIPHERAL ARTERIAL LINE FOR AN EXCHANGE TRANSFUSION. THE CATHETER WAS INSERTED AND THEN A 5-INCH MICROBORE EXTENSION SET WAS ATTACHED. THE ATTENDING INSERTED THE MALE TIP INTO THE CATHETER HUB AND ATTEMPTED TO LUER LOCK THE CATHETER AND EXTENSION SET. THE LUER LOCK WOULD NOT COMPLETELY LOCK AND THE INFANT LOST 2ML OF BLOOD. A NEW LINE HAD TO BE REINSERTED. ACCORDING TO THE ATTENDING, THIS IS NOT THE FIRST TIME THIS HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * TUBING, IV FPA HOSPIRA GLOBAL MEDICAL AFFAIRS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 24 DA