BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3052481 · Received April 11, 2013

    Report

    Report Number
    1416980-2013-09024
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 21, 2013
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    BRZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE SAMPLE CONTAMINATED WITH BLOOD WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED A CUT IN THE TUBE APPROXIMATELY 10 CM BELOW THE DRIP CHAMBER. THE REPORTED CONDITION WAS CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THERE WAS A HOLE IN A FLO-GARD 6201G COMPATIBLE BLOOD SET. THIS CONDITION WAS NOTICED WHILE BLOOD WAS BEING RUN THROUGH THE SET PRIOR TO PATIENT CONNECTION. THERE IS NO REPORT OF PATIENT INVOLVEMENT, INJURY/ADVERSE EVENTS, OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156045 ACCESS SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE - MALTA 12J24V140

    Patients

    Seq Age Sex Outcome Treatment
    1