BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTEND LIFE PD TRANSFER SET - JAPAN

    MDR report key: 1905595 · Received November 23, 2010

    Report

    Report Number
    1423500-2010-06116
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A TWIST CLAMP THAT WAS HARD TO TURN WAS CONFIRMED IN THE LAB. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THE ROOT CAUSE REMAINS UNDETERMINED. 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). THE DEVICE/PRODUCT SAMPLE HAS BEEN RECEIVED BY BAXTER; HOWEVER, THE EVALUATION HAS NOT BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED. THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    A NURSE REPORTED, THE SLEEVE OF A MINICAP TRANSFER SET WAS TOO TIGHT TO OPEN AND CLOSE. THIS WAS FOUND JUST AFTER THE SET WAS CHANGED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1