BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3051302 · Received April 10, 2013

    Report

    Report Number
    1416980-2013-08973
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET HAD LEAKED. AFTER THE NURSE HUNG A BAG OF CHEMOTHERAPY, THE SET BEGAN LEAKING JUST BELOW THE LOWER Y-SITE. THE NURSE NOTED THAT THE TUBING HAD SEPARATED, THUS THE SET HAD LEAKED. THERE WAS NO PATIENT OR STAFF EXPOSURE TO THE CHEMOTHERAPY SOLUTION, AS THE LEAK WAS CONTAINED AND SET ASIDE. THERE WAS PATIENT INVOLVEMENT; HOWEVER THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, NOR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148366 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R13A08030

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN BAG, UNKNOWN CHEMOTHERAPY