BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4182246 · Received October 17, 2014

    Report

    Report Number
    1416980-2014-36336
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 23, 2014
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K132734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ACTUAL DEVICE WAS EVALUATED. VISUAL INSPECTION OF THE DEVICE DID NOT REVEAL ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL TESTING WAS PERFORMED BY CHECKING THE FUNCTIONALITY OF THE SLIDE CLAMPS AND THE FLOW THROUGH THE DEVICE AND DID NOT REVEAL ANY ABNORMALITIES. PRESSURE TESTING WAS PERFORMED BY SUBMERGING THE DEVICE UNDERWATER AND DID NOT REVEAL ANY ABNORMALITIES. THE CONDITION COULD NOT BE VERIFIED. 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 FLUSH. THE REPORTER STATED THAT BLOOD WAS DRAWN THROUGH THE CONNECTOR AND THE NURSE TRIED FLUSHING THE CONNECTOR WITH A SYRINGE FILLED WITH NORMAL SALINE; THE BLOOD WOULD NOT CLEAR. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662282 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SYRINGE, NORMAL SALINE