BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2233316 · Received September 2, 2011

    Report

    Report Number
    1423500-2011-11634
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    July 13, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS CONFIRMED IN THE LAB. VISUAL EVALUATION FOUND THE END OF THE OVER POUCH OPENED/UNSEALED. THIS PROBLEM INDICATES AN INCOMPLETE OR WEAK SEAL WHICH EXISTED DURING MANUFACTURING, STRESSED FURTHER BY THE VACUUM AND PRESSURIZATION OF THE STERILIZATION CYCLE, PLUS ANY MIS-HANDLING DURING TRANSPORTATION. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS IS AN INTERNATIONAL REPORT OF A MINI CAP POUCH THAT WAS DAMAGED OUT OF THE CARTON. THERE WAS NO PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED ALONG WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H11A31042

    Patients

    Seq Age Sex Outcome Treatment
    1