BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 4032368 · Received August 25, 2014

    Report

    Report Number
    1416980-2014-27833
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 28, 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

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR LOT NUMBER GM1401021 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION NOTED. AS THE SAMPLE WAS NOT RETURNED FOR EVALUATION, A COMPLETE DEVICE ANALYSIS COULD NOT BE COMPLETED. THE CAUSE OF THE REPORTED EVENT COULD NOT BE VERIFIED AND THE CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SPONGE OF A MINICAP WAS ¿OUT OF MINICAP¿. THIS WAS FOUND BEFORE USE. THERE IS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512951 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - GUANGZHOU GM1401021

    Patients

    Seq Age Sex Outcome Treatment
    1