BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2930185 · Received January 25, 2013

    Report

    Report Number
    1416980-2013-02003
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 24, 2012
    Report Date
    January 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED BY BAXTER. THIS COMPLAINT FOR A REPORT OF LEAK 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 VISUAL INSPECTION CONFIRMED A VISIBLE CRACK ON THE CAP ABOVE THE FINGER GRIP AREA. A FUNCTIONAL TEST AND A LEAK TEST WERE PERFORMED WITH NO ISSUES NOTED.

    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 RELEVANT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A PATIENT REPORTED TO BAXTER THAT ON (B)(6) 2012 WHEN HE CONNECTED A MINICAP TO HIS TRANSFER SET AFTER HE COMPLETED DIALYSIS, THE MINICAP LEAKED A SMALL AMOUNT OF BETADINE THROUGH TINY CRACKS IN THE MINICAP. THE PATIENT REPLACED THE CAP WITH A NEW ONE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35154 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - SWINFORD 12C26H16

    Patients

    Seq Age Sex Outcome Treatment
    1