BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3900743 · Received June 27, 2014

    Report

    Report Number
    1416980-2014-20761
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Report Date
    June 5, 2014
    Manufacturer
    BAXTER MANUFACTURING FACILITY
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOME PATIENT (HP) WHO EXPERIENCED A CONNECTION ISSUE BETWEEN THE TRANSFER SET AND A NON-BAXTER CATHETER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377215 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER MANUFACTURING FACILITY

    Patients

    Seq Age Sex Outcome Treatment
    1