BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2972975 · Received February 21, 2013

    Report

    Report Number
    1416980-2013-04399
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    February 7, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K120443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXACT DATE OF THIS EVENT IS UNKNOWN; HOWEVER, THE EVENT OCCURRED DURING (B)(6) 2013. THE SAMPLE WAS NOT RECEIVED FOR EVALUATION. THE CUSTOMER'S REPORTED PROBLEM WAS NOT CONFIRMED; THE ROOT CAUSE WAS NOT IDENTIFIED. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ONE-LINK CONNECTOR 'BECAME OCCLUDED.' THE CUSTOMER INFORMED THAT THE PATIENT'S PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE WAS THOUGHT TO BE CLOTTING. THE FACILITY FOUND THAT THEY WERE UNABLE TO FLUSH THE PICC WITH THE ONE-LINK ATTACHED. AFTER THE ONE-LINK WAS REPLACED THE USER WAS ABLE TO FLUSH THE PICC. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR 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
    76368 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 PERIPHERALLY INSERTED CENTRAL CATHETER