BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING TITANIUM ADAPTER

    MDR report key: 2820676 · Received November 6, 2012

    Report

    Report Number
    1416980-2012-04131
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 22, 2012
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE WAS NOT CONFIRMED. THE DEVICE WAS NOT RETURNED TO BAXTER, PRECLUDING FURTHER DEVICE INVESTIGATION. AS A RESULT, AN ASSIGNABLE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. THIS PRODUCT IS NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510(K) NUMBER.

    Description of Event or Problem · 1

    A NURSE CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A DISCONNECTION ISSUE BETWEEN A UV TRANSFER SET AND A TITANIUM ADAPTER THAT OCCURRED DURING USE. THIS REPORT RELATES TO THE TITANIUM ADAPTER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 UV TRANSFER SET