BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3123914 · Received May 22, 2013

    Report

    Report Number
    1416980-2013-13109
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Report Date
    May 2, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    BRZ
    PMA / PMN Number
    K993120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE SAMPLE EVALUATION COULD NOT BE PERFORMED DUE TO A NON-BAXTER PRODUCT BEING RETURNED INSTEAD OF THE ORIGINAL REQUESTED SAMPLE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTERLINK Y-TYPE BLOOD SOLUTION SET LEAKED DURING INFUSION. THERE WAS NO INFORMATION ON THE LOCATION OF THE LEAK. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226041 ACCESS SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE R12F14111

    Patients

    Seq Age Sex Outcome Treatment
    1