BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOLINK MICROBORE CATH EXT SETW/POSITIVE FLUID DISPLACEMENT

    MDR report key: 1994119 · Received February 16, 2011

    Report

    Report Number
    6000001-2011-01104
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 9, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K042936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION WAS CAUSED BY AN UNKNOWN REASON. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4) AN ACTUAL SAMPLE WAS EVALUATED BY A BAXTER QUALITY ASSOCIATE IN WHICH A BLOCKAGE OCCURRED IN THE TUBING NEAR THE ONE PIECE LUER LOCK. VISUAL AND FUNCTIONAL TESTS WERE PERFORMED, AND THE BLOCKAGE WAS CONFIRMED. IN ADDITION, THE ACTUAL SAMPLE FAILED TO CLEAR PASSAGE AT 8PSI.

    Description of Event or Problem · 1

    BAXTER'S QUALITY ASSOCIATE REPORTED A FLOLINK MICROBORE CATHETER EXTENSION SET THAT HAD A BLOCKAGE IN THE TUBING BY ONE PIECE LUER LOCK.THIS REPORTED CONDITION WAS DISCOVERED DURING AN EVALUATION BY THE ASSOSICATE. THE SAMPLE FAILED TO CLEAR PASSAGE AT 8PSI; IN WHICH PRIMING COULD NOT BE PERFORMED. THERE WAS NO PATIENT INVOLVEMENT OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOLINK MICROBORE CATH EXT SETW/POSITIVE FLUID DISPLACEMENT SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO UR10H20033

    Patients

    Seq Age Sex Outcome Treatment
    1