BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING TITANIUM ADAPTER

    MDR report key: 2771826 · Received October 4, 2012

    Report

    Report Number
    1416980-2012-01520
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 13, 2012
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. THIS COMPLAINT FOR A LEAK WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE SAMPLE WAS NOT RETURNED TO BAXTER; THEREFORE NO EVALUATION COULD BE PERFORMED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Description of Event or Problem · 1

    A NURSE CONTACTED BAXTER (B)(4) REGARDING A LEAK FROM A LOCKING TITANIUM ADAPTOR. THE NURSE STATED THAT LEAKAGE WAS NOTICED FROM THE CONNECTION SPOT BETWEEN A TRANSFER SET AND TITANIUM ADAPTOR. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING TITANIUM ADAPTER SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD 11F24H35

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR TRANSFER SET