BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2942022 · Received February 4, 2013

    Report

    Report Number
    1416980-2013-02816
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 15, 2013
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE ACTUAL SAMPLE HAS BEEN MADE. SHOULD THE ACTUAL SAMPLE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY RELEVANT ADDITIONAL INFORMATION BECOMES AVAILABLE. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROBLEM WAS CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A EVALUATION OF THE ACTUAL SAMPLE WAS CONDUCTED AND ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION OF A LEAK DURING THE EVALUATION. THE SAMPLE HAD A CRACK ON IT ABOVE THE FINGER GRIP THE MINICAP PASSED DIMENSIONAL ANALYSIS BUT FAILED VISUAL INSPECTION AND FAILED FUNCTIONAL TESTING.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED BY BAXTER (B)(4) FROM A CUSTOMER REGARDING A MINICAP WHICH HAD A CRACK, WHERE THE IODINE IS LOCATED, AND WAS LEAKING DURING USE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION WAS ASSOCIATED WITH THE REPORTED CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45808 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - SWINFORD 12E10H15

    Patients

    Seq Age Sex Outcome Treatment
    1