BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2942174 · Received February 4, 2013

    Report

    Report Number
    1416980-2013-02838
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 23, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. A BATCH REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. IF THE SAMPLE IS RECEIVED OR ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE WAS RETURNED FOR EVALUATION. DURING VISUAL INSPECTION A RUPTURE, APPROXIMATELY 1/2 INCH IN LENGTH, WAS FOUND IN THE TUBING. THE RUPTURE WAS LOCATED BETWEEN THE BOTTOM Y-SITE AND MALE LUER. THE CAUSE OF THE REPORTED MALFUNCTION WAS DETERMINED TO BE RELATED TO THE USER. THIS PRODUCT IS NOT APPROVED FOR USE WITH A POWER INJECTOR. THE LABEL COPY WAS DETERMINED TO BE APPROPRIATE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE A CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET WHICH BURST WHILE BEING USED WITH A POWER INJECTOR. ACCORDING TO THE REPORT, A NURSE CONNECTED A POWER INJECTOR TO THE MOST DISTAL Y-SITE (CLOSEST TO THE PATIENT) AND BEGAN INJECTING CONTRAST AT AN UNKNOWN FLOW RATE. WHILE INJECTING THE CONTRAST, THE TUBING RUPTURED BETWEEN THE Y-SITE AND THE MALE LUER WHICH WAS CONNECTED DIRECTLY TO THE PATIENT'S CATHETER. A SLIGHT AMOUNT OF BLOOD BACKED UP INTO THE TUBING AND GOT ON THE PATIENT AND THE FLOOR. NORMAL SALINE 0.9% WAS BEING INFUSED PRIOR TO THE EVENT. 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
    46440 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1