BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPD SOLUTION TRANSFER SET (SHORT) FOR UV-FLASH

    MDR report key: 1201227 · Received October 20, 2008

    Report

    Report Number
    1423500-2007-00162
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    April 3, 2007
    Report Date
    April 3, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA ON MAY 01, 2007. EVALUATION SUMMARY; RESULTS INDICATE CONFIRMATION OF THE REPORTED EVENT. THERE HAS BEEN CORRECTIVE AND PREVENTIVE ACTION TAKEN RELATIVE TO THIS MATTER. RENAL PRODUCT SURVEILLANCE, QUALITY ENGINEERING, AND PLANT MANUFACTURING WILL CONTINUE TO MONITOR THIS PRODUCT LINE.

    Description of Event or Problem · 1

    DURING THE EVALUATION OF A RETURNED TRANSFER SET, THE SPIKE WAS FOUND TO BE CRACKED / BROKEN. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPD SOLUTION TRANSFER SET (SHORT) FOR UV-FLASH TRANSFER SETS KDJ BAXTER HEALTHCARE CORPORATION NA H06A19077

    Patients

    Seq Age Sex Outcome Treatment
    1