BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPD DISCONNECT Y-SET, BULKPACK DISPOSABLE

    MDR report key: 1113306 · Received August 12, 2008

    Report

    Report Number
    1423500-2008-00742
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 23, 2008
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    K961825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). BATCH REVIEW OF THE REPORTED LOT NOTED NO ISSUES. RENAL PRODUCT SURVEILLANCE, QUALITY ENGINEERING, AND PLANT MANUFACTURING WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS, AND TAKE CORRECTIVE / PREVENTATIVE ACTION AS APPROPRIATE.

    Description of Event or Problem · 1

    A PATIENT CONTACTED BAXTER REGARDING PINHOLES IN THE DRAIN BAGS OF 2 Y-SETS. THE PATIENT STATES THAT HE BELIEVES THEY ARE GETTING 'PINCHED' IN THE MACHINERY DURING MANUFACTURING. THE PATIENT STATED THAT THE BOX AND PACKAGING OF THE Y-SETS WERE FINE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPD DISCONNECT Y-SET, BULKPACK DISPOSABLE Y-SET / 78KDJ KDJ BAXTER HEALTHCARE CORPORATION H08C27017

    Patients

    Seq Age Sex Outcome Treatment
    1