BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3900735 · Received June 27, 2014

    Report

    Report Number
    1416980-2014-20758
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Report Date
    June 4, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    BRZ
    PMA / PMN Number
    K993120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERLINK BLOOD SET¿S SPIKE WAS ¿NOT LONG ENOUGH TO PIERCE THE BLOOD BAG¿. IN ORDER TO SPIKE THE BAG THE USER CUT THE BAG WITH A SCALPEL AND THEN INSERTED THE SPIKE. THE CUSTOMER NOTED THAT BLOOD LEAKED OUT OF THE BAG. THIS MALFUNCTION OCCURRED DURING SET-UP. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377760 ACCESS SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1