BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4928807 · Received July 21, 2015

    Report

    Report Number
    1416980-2015-29595
    Event Type
    Malfunction
    Date Received
    July 21, 2015
    Date of Event
    June 25, 2015
    Report Date
    July 2, 2015
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K811078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER OF THIS DEVICE WAS REPORTED TO BE 941364; HOWEVER, THAT LOT NUMBER DOES NOT EXIST. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBING OF A CATHETER EXTENSION SET BECAME SEPARATED AT A SOLVENT BOND. THIS OCCURRED DURING PRIMING WITH A NEUTRAL FLUID. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472029 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1