BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2082324 · Received May 9, 2011

    Report

    Report Number
    6000001-2011-03809
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 19, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K960787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN RECEIVED AND IS CURRENTLY BEING EVALUATED. ONCE THE SAMPLE HAS BEEN EVALUATED A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE WAS SUBMITTED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTS WERE PERFORMED, AND THE REPORTED CONDITION WAS CONFIRMED. THE DEFECT WAS CONFIRMED DURING AN 8 PSI PRESSURE TEST. THE LEAK WAS FOUND BETWEEN THE BURETTE AND THE BURETTE BOTTOM CAP, WHERE THE Y-VINYL IS ASSEMBLED. THE CAUSE OF THIS CONFIRMED CONDITION IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) OF A LEAKAGE FROM AN IRRIGATION SET DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT HOWEVER THERE WAS NO PATIENT INJURY REPORTED. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SOLUTION