BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3081888 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10626
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 4, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K112893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEARLINK Y-TYPE CATHETER EXTENSION SET EXPERIENCED A NO-FLOW. THE SOFT TUBING, NEAR THE MALE LUER LOCK ADAPTOR, WAS TAPED TO THE PATIENT'S SKIN. THE TUBING WAS LOOPED BACKWARDS AND TAPED ONTO THE PATIENT'S SKIN AGAIN. THE NO-FLOW WAS IDENTIFIED DURING THE PATIENTS POST OPERATIVE RECOVERY. THE USER NOTICED THAT THE TUBING WAS KINKED WHERE THE TUBING WAS LOOPED BACK. AS SOON AS THE ANESTHESIOLOGIST DETECTED THE KINK IT WAS STRAIGHTENED OUT; RESOLVING THE REPORTED MALFUNCTION. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185263 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R12B20042

    Patients

    Seq Age Sex Outcome Treatment
    1