BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI-CAP, WITH POVIDONE-IODINE

    MDR report key: 1993952 · Received February 16, 2011

    Report

    Report Number
    1423500-2011-02046
    Event Type
    Malfunction
    Date Received
    February 16, 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). NO SAMPLE RETURNED FOR THE EVALUATION, THE COMPLAINT WAS NOT CONFIRMED AND NO ASSIGNABLE CAUSE COULD BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    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.

    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 GM1007014

    Patients

    Seq Age Sex Outcome Treatment
    1