BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 3972580 · Received August 1, 2014

    Report

    Report Number
    1416980-2014-24959
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    July 8, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS MANUFACTURED BETWEEN THE DATES OF 04/24/2014 AND 05/02/2014. THE SAMPLE WAS RETURNED TO BAXTER AND AN EVALUATION WAS COMPLETED. A VISUAL INSPECTION WAS PERFORMED AND THE PRESENCE OF IODINE WAS DETECTED ON THE SAMPLE. PRESSURE TESTING WAS PERFORMED ON THE SAMPLE WITH NO ISSUES NOTED. A WEIGHT CHECK WAS PERFORMED ON THE DEVICE AND VERIFIED THAT AN ADEQUATE AMOUNT OF BETADINE WAS DISPENSED IN THE MINICAP. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS CONDUCTED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. UPON CONCLUSION OF THE INVESTIGATION, THE REPORTED PROBLEM COULD NOT BE VERIFIED AND A CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POVIDONE-IODINE ON THE SPONGE OF A MINICAP WAS ¿ALMOST DRIED OUT.¿ THIS WAS NOTED UPON OPENING THE FOIL PACKAGING. THE REPORTER STATED THAT THERE WAS NO NOTICEABLE DAMAGE TO THE FOIL PACKAGING OR THE SHIPPING CARTON. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450213 MINICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDI BAXTER HEALTHCARE - CLEVELAND GD896936

    Patients

    Seq Age Sex Outcome Treatment
    1