BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 4012884 · Received August 15, 2014

    Report

    Report Number
    1416980-2014-26603
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Report Date
    July 23, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE ANALYSIS COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MINICAP WITH POVIDONE-IODINE SOLUTION DID NOT CONTAIN ENOUGH IODINE IN THE SPONGE. THE PATIENT REPORTED THE SPONGE TO BE CREAM COLORED INSTEAD OF THE USUAL DARK BROWN COLOR. THIS OCCURRED BEFORE USE, AS THE PATIENT WAS SETTING UP FOR THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 40 OF 45.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489546 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1