BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2895758 · Received January 3, 2013

    Report

    Report Number
    1416980-2013-00233
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 11, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: THIS COMPLAINT WAS NOT CONFIRMED AND THE ROOT CAUSE WAS NOT DETERMINED. THE SAMPLE WAS NOT RETURNED TO BAXTER, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A BAXTER REPRESENTATIVE REPORTED TO BAXTER (B)(4) A CONNECTION ISSUE WITH A TITANIUM ADAPTOR. IT WAS REPORTED THAT THE CATHETER CONNECTOR OF THE MINICAP TRANSFER SET COULD NOT BE CONNECTED WITH THE TITANIUM ADAPTOR WHEN THE NURSE OPENED THE PACKING. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT INJURY AND NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2594 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 TRANSFER SET