BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2851518 · Received November 29, 2012

    Report

    Report Number
    1416980-2012-06158
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 7, 2012
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K120443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    BAXTER SALES REPRESENTATIVE REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE A ONE-LINK LUER ACTIVATED DEVICE IN WHICH A NO FLOW WAS OBSERVED. ACCORDING TO THE REPORT, DURING THE SALES REPRESENTATIVE'S FOLLOW-UP, A NURSE INDICATED THAT A NO FLOW WAS EXPERIENCED AT AN UNKNOWN TIME DURING THERAPY. THE NURSE INDICATED THAT THE ONE-LINK WAS ATTACHED TO AN UNKNOWN J-LOOP EXTENSION SET. THE NURSE ATTEMPTED TO DISCONNECT AND RECONNECT MULTIPLES TIMES. AFTER AN UNKNOWN AMOUNT OF ATTEMPTS, FLOW WAS ESTABLISHED. THE FACILITY CONVERTED FROM MAX-PLUS. THERE WERE NO REPORTS OF PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN J-LOOP EXTENSION SET