BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2903914 · Received January 9, 2013

    Report

    Report Number
    1416980-2013-00603
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 17, 2012
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K120443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE FOR EVALUATION, THEREFORE THE REPORTED CONDITION COULD NOT BE CONFIRMED OR DUPLICATED AND AN ASSIGNABLE CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    THE FACILITY CONTACTED BAXTER (B)(4) TECHNICAL SERVICES TO REPORT A ONE-LINK NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT THAT HAS A CONNECTION ISSUE. THE "IV TUBING BECOMES DISCONNECTED WITH ONE-LINK CAP. CAP STAYED CONNECTED TO T-PIECE OF IV BUT WAS DISCONNECTED FROM IV TUBING". IT IS UNKNOWN WHEN THIS MALFUNCTION WAS OBSERVED. IT IS UNKNOWN IF THERE WAS A PATIENT INVOLVED; THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11795 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO 2002875

    Patients

    Seq Age Sex Outcome Treatment
    1