BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK CONTINU-FLO 4-WAY STOPCOCK EXT SET

    MDR report key: 1932591 · Received December 18, 2010

    Report

    Report Number
    6000001-2010-05994
    Event Type
    Malfunction
    Date Received
    December 18, 2010
    Date of Event
    May 1, 2010
    Report Date
    May 18, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FMG
    PMA / PMN Number
    K962581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. BATCH REVIEW WAS PERFORMED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING OF THIS LOT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE OF AN INTERLINK CONTINU-FLO 4-WAY STOPCOCK EXTENSION SET WHERE THE FLUID WAS NOT RUNNING THROUGH THE IV SET. THE CUSTOMER IS NOT INVERTING AND TAPPING THE CHECK VALVE PER LABEL COPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK CONTINU-FLO 4-WAY STOPCOCK EXT SET STOPCOCK, I.V. SET FMG BAXTER HEALTHCARE - AIBONITO UR10D08078

    Patients

    Seq Age Sex Outcome Treatment
    1