BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2873407 · Received December 14, 2012

    Report

    Report Number
    1416980-2012-07344
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K112893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE CAN NOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 SALES REP CALLED BAXTER CORPORATE PRODUCT SURVEILLANCE TO REPORT A CLEARLINK CATHETER EXTENSION SET WHICH THE SET BURST. ACCORDING TO THE REPORT, THE EXTENSION SET WAS CONNECTED TO A PICC LINE CATHETER. AFTER THE CONTRAST WAS INJECTED INTO A 22 GAUGE CATHETER AT A FLOW RATE OF 1.5 ML/SEC, THE STAFF HEARD A "POP" AND INSPECTED THE PATIENT. THE TUBING OF THE EXTENSION SET SPLIT DOWN THE MIDDLE AND BLOOD LEAKED OUT OF THE SET. THEY CHANGED OUT THE SET AND PROCEEDED WITH THE PROCEDURE. THE EVENT OCCURRED DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO UR12J02127

    Patients

    Seq Age Sex Outcome Treatment
    1