BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 3951253 · Received July 22, 2014

    Report

    Report Number
    1416980-2014-23743
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Report Date
    June 27, 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
    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). CORRECTION: THE MANUFACTURING DATE FOR THIS LOT WAS 04/24/14-05/2/14. ADDITIONAL INFORMATION: A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR LOT NUMBER GD896936 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION NOTED. AN ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED AND THE SPONGE WAS PRESENT IN THE MINICAPS. THE REPORTED EVENT COULD NOT BE VERIFIED AND THE DEVICE WAS DETERMINED TO MEET ALL SPECIFICATIONS RELATED TO THE REPORTED EVENT. 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 FELL OUT OF THE DEVICE BEFORE USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427804 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD896936

    Patients

    Seq Age Sex Outcome Treatment
    1