BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI-CAP, WITH POVIDONE-IODINE

    MDR report key: 1992294 · Received February 15, 2011

    Report

    Report Number
    1423500-2011-02020
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 12, 2010
    Report Date
    January 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - GUANGZHOU
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. THE SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. HOWEVER, THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION AS OF YET. IF THE SAMPLE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). NO SAMPLE WAS RETURNED, SO AN EVALUATION COULD NOT BE PERFORMED, AND AN ASSIGNABLE CAUSE COULD NOT BE DETERMINED. A REVIEW OF FILE OF THE BATCH REPORTED REVEALED NO ANY EXCEPTION REGARDS THIS ISSUE FOUND IN THE MANUFACTURING PROCESS. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) THAT THE BETADINE SPONGE CAME LOOSE FROM THE MINICAP. THIS WAS DURING USE. THERE WAS PATIENT INVOLVEMENT BUT NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-CAP, WITH POVIDONE-IODINE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - GUANGZHOU GM1004012

    Patients

    Seq Age Sex Outcome Treatment
    1