BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4926427 · Received July 20, 2015

    Report

    Report Number
    1416980-2015-29533
    Event Type
    Malfunction
    Date Received
    July 20, 2015
    Report Date
    June 25, 2015
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K132734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED POTENTIALLY ASSOCIATED LOT NUMBER UR15E006025. THE CUSTOMER STATED THIS EVENT MAY HAVE OCCURRED SOMETIME WITHIN THE LAST THREE MONTHS OF (B)(6) 2015. 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 A ONE-LINK CATHETER EXTENSION SET HAD NO FLOW. ACCORDING TO THE REPORT, THE ONE-LINK EXTENSION SET WAS ATTACHED TO A NON-BAXTER SET. THE NURSE STATED ¿THAT EVEN AFTER THE SET WAS PRIMED, WHEN THE ONE LINK SET WAS CONNECTED TO THE CATHETER, THERE WAS NO FLOW.¿ THE CLINICIAN DISCONNECTED THE SET, REMOVED THE ONE LINK CAP, AND REATTACHED THE TUBING DIRECTLY TO THE CATHETER TO INFUSE THE PATIENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468348 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN B BRAUN SET| PATIENT CATHETER| UNKNOWN SOLUTION