BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4943299 · Received July 27, 2015

    Report

    Report Number
    1416980-2015-30283
    Event Type
    Malfunction
    Date Received
    July 27, 2015
    Date of Event
    July 2, 2015
    Report Date
    July 2, 2015
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K132734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. A FUNCTIONAL TEST WAS THEN PERFORMED IN WHICH THE DEVICE WAS PRIMED USING THE INSTRUCTIONS ON ITS LABEL COPY AND OBSERVED FOR ISSUES; NO ISSUES WERE NOTED. CLEAR PASSAGE AND PRESSURE TESTING WERE PERFORMED, AND THE DEVICE PASSED BOTH TESTS. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE REPORTED CONDITION WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). 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 IV CONNECTOR WOULD NOT CONNECT TO A NON-BAXTER SYRINGE. THIS OCCURRED DURING SET UP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486272 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO UR15D11028

    Patients

    Seq Age Sex Outcome Treatment
    1