BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING TITANIUM ADAPTER

    MDR report key: 2884181 · Received December 21, 2012

    Report

    Report Number
    1416980-2012-07997
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 17, 2012
    Report Date
    November 29, 2012
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K894783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED TO BAXTER, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A CONNECTION ISSUE WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A COMPANY REPRESENTATIVE CONTACTED BAXTER (B)(4) REGARDING A CONNECTION ISSUE WITH A TITANIUM ADAPTOR. THE REPRESENTATIVE STATED THAT THE TRANSFER SET WAS NOT CONNECTED TO THE TITANIUM ADAPTOR TIGHTLY. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED ALONG WITH THIS EVENT.

    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 TRANSFER SET