BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 4223022 · Received November 4, 2014

    Report

    Report Number
    1416980-2014-38657
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Report Date
    October 10, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). AS THE MINICAP WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IODINE OF THE MINICAP WAS IN THE POUCH AND NOT IN THE MINICAP. THE PATIENT STATED THE MINICAP WAS PARTIALLY DRY. THE PATIENT STATED THE SPONGE HAD IODINE IN IT BUT NOT TOWARDS THE TOP OF THE SPONGE. THE PACKAGING WAS NOT OPENED OR DAMAGED PRIOR TO USE AND THE MINICAP WAS STORED AT ROOM TEMPERATURE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707920 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1