BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3115498 · Received May 16, 2013

    Report

    Report Number
    1416980-2013-12480
    Event Type
    Malfunction
    Date Received
    May 16, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K921899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: BAXTER RECEIVED A PHOTO OF THE SAMPLE FOR EVALUATION. PHOTOGRAPHIC EVALUATION DID NOT NOTE A SLICE IN THE TUBING. THEREFORE THE CAUSE COULD NOT BE IDENTIFIED. NO ADDITIONAL OBSERVATION WAS NOTED FROM THE PHOTO.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXACT AGE OF THE PATIENT IS UNKNOWN, HOWEVER IT WAS REPORTED THAT THEY ARE A (B)(6). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BAXTER PRODUCT SURVEILLANCE RECEIVED A REPORT REGARDING AN ISSUE WITH A ONE INTERLINK EXTENSION SET (INTERLINK T-CON EXT SET/MICRO-BORE W/MLL ADT (B)(4)). ACCORDING TO THE REPORT, THIS EXTENSION SET EXHIBITED A SLICE JUST BELOW WHERE THE INJECTION SITE AND THE TUBING MEETS. THIS SLICE RESULTED IN A LOSS OF 5-10 MLS OF BLOOD. THE EVENT WAS NOTED DURING PATIENT USE BUT THERE WAS NO INDICATION THAT THE EVENT RESULTED IN INJURY OR ADVERSE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216906 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1