BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3081653 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10596
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    BRZ
    PMA / PMN Number
    K993120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). A PHOTO WAS RECEIVED FOR EVALUATION. THE PHOTO WAS INSPECTED AND IT VISUALLY CONFIRMED THE SEPARATION BETWEEN THE SPIKE AND THE TUBING. THE CAUSE COULD NOT BE DETERMINED AS THE ACTUAL SAMPLE WAS NOT RETURNED FOR EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEARLINK Y-TYPE BLOOD SET HAD SEPARATED. PRIOR TO PATIENT USE, THE SET TUBING HAD SEPARATED FROM THE BASE OF THE SPIKE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185586 ACCESS SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1