BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 3200119 · Received July 1, 2013

    Report

    Report Number
    1416980-2013-16920
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Report Date
    June 6, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER INDICATED THAT THE SAMPLE WAS DISCARDED. AS A RESULT, A SAMPLE ANALYSIS CANNOT BE COMPLETED. 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 GD893875 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 THE MINICAP DID NOT HAVE ANY IODINE AND THAT THE SPONGE INSIDE THE MINICAP APPEARED TO BE DRY BEFORE IT WAS USED. THE HP STATED THAT THERE WAS NO DAMAGE TO THE OUTER POUCH OF THE MINICAP OR THE BOX ITSELF. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 13 OF 15.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297523 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD893875

    Patients

    Seq Age Sex Outcome Treatment
    1