BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3973788 · Received August 1, 2014

    Report

    Report Number
    1416980-2014-25123
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K132734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE SAMPLE WAS NOT RETURNED FOR EVALUATION, THEREFORE THE REPORTED CONDITION COULD NOT BE VERIFIED AND THE CAUSE COULD NOT BE IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ONE LINK BONDED MICRO BORE EXTENSION SET HAD A LEAK. THE LEAK OCCURRED UPON DISCONNECTION OF THE SYRINGE (NON-BAXTER PRODUCT). THE ONE LINK EXTENSION SET AND CATHETER (NON-BAXTER) WERE PRIMED WITH NORMAL SALINE. WHEN THE 3ML SYRINGE WAS CONNECTED TO THE ONE LINK BLOOD SPRAYED INTO THE SYRINGE. THE SYRINGE WAS DISCONNECTED AND A SMALL AMOUNT OF BLOOD MIXED WITH SALINE SPILLED ON THE FLOOR. THE SYRINGE CONTAINED A CHEMO/NUCLEAR TRACER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451338 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 CATHETER| BD 3ML SYRINGE