BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2841848 · Received November 21, 2012

    Report

    Report Number
    1416980-2012-05708
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 30, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THIS COMPLAINT WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED WITH NO TEARS DETECTED IN THE POUCH. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ADDITIONAL INFORMATION: A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PRODUCT. A DEVICE HISTORY REVIEW WAS PERFORMED WITH NO EXCEPTIONS DURING MANUFACTURING FOUND.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER A PACKAGING RELATED ISSUE FOUND BEFORE USE. THE CUSTOMER REPORTED THAT THE OUTER PACKAGING OF MINICAP TRANSFER SET WAS FOUND TORN BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT, INJURY AND NO MEDICAL INTERVENTION RELATED TO THIS EVENT.

    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 H11J03043

    Patients

    Seq Age Sex Outcome Treatment
    1