BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOLINK MICROBORE CATH EXT SETW/POSITIVE FLUID DISPLACEMENT

    MDR report key: 1992157 · Received February 15, 2011

    Report

    Report Number
    6000001-2011-01014
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K042936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)BAXTER HAS CONDUCTED AN INVESTIGATION, AND THE ROOT CAUSE IS UNKNOWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL AND COMPANION SAMPLE WERE RECEIVED FOR EVALUATION PURPOSES RELATED TO DIFFICULT TO PRIME CONDITION. VISUAL AND FUNCTIONAL TESTS WERE PERFORMED, AND THE REPORTED CONDITION WAS CONFIRMED ON THE ACTUAL AND NOT THE COMPANION SAMPLE. DURING THE VISUAL INSPECTION IT WAS NOTICED THAT THERE WAS A BLOCKAGE IN THE TUBING AT THE LOW PROFILE ONE PIECE LUER LOCK. IN ADDITION, THE ACTUAL SAMPLE FAILED TO CLEAR PASSAGE AT 8PSI. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) OF A FLOLINK MICROBORE CATHETER EXTENSION SET THAT WOULD NOT PRIME. THE CUSTOMER IS ASSUMING THAT THE ISSUE IS WITH THE TUBING RATHER THAN THE FLOLINK LUER. THERE WAS NO PATIENT INVOLVEMENT. 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 UNKNOWN SOLUTION