BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 4130255 · Received September 30, 2014

    Report

    Report Number
    1416980-2014-33891
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BAXTER HEALTHCARE - GUANGZHOU
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). THE PATIENT WAS REPORTED TO LIVE NEAR (B)(6). EVALUATION SUMMARY: A DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE DEVICE HAD BEEN OPENED. THE SPONGE WAS FOUND TO BE DRY. THE REPORTED PROBLEM WAS IDENTIFIED, BUT THE CAUSE COULD NOT BE DETERMINED. FIVE RETENTION SAMPLES WERE THEN EVALUATED; EACH OF THESE SAMPLES PASSED SPLIT PRESSURE TESTING, AND EACH OF THESE SAMPLE'S SPONGES HAD ADEQUATE IODINE AND WERE NOT DRY. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MINICAP HAD A DRY BETADINE SPONGE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607060 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - GUANGZHOU GM1311006

    Patients

    Seq Age Sex Outcome Treatment
    1