BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 5502130 · Received March 15, 2016

    Report

    Report Number
    1416980-2016-05276
    Event Type
    Malfunction
    Date Received
    March 15, 2016
    Report Date
    March 15, 2016
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDJ
    PMA / PMN Number
    K152129
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). MANUFACTURING DATE: 11/17/1205-11/23/2015. AS THE PRODUCT WAS NOT RETURNED, A DEVICE ANALYSIS COULD NOT BE COMPLETED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IODINE SPONGE OF A MINICAP CONTAINED NO BETADINE. THIS WAS NOTED BEFORE USE AND THE PRODUCT WAS DISCARDED. THE SPONGE WAS DRY AND WHITE IN COLOR. THERE WAS NO VISIBLE DAMAGE TO THE FOIL POUCH BEFORE IT WAS OPENED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157038 MINICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - CLEVELAND GD900720

    Patients

    Seq Age Sex Outcome Treatment
    1