BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 3033371 · Received April 3, 2013

    Report

    Report Number
    1416980-2013-08257
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    BAXTER HEALTHCARE - CUERNAVACA
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GT
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. HOWEVER, THE SAMPLE HAS NOT YET BEEN RECEIVED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PROBLEM WAS CONFIRMED DURING EVALUATION OF THE RETURNED SAMPLE AND THE CAUSE WAS DETERMINED TO BE AN ISSUE THAT OCCURRED OUTSIDE THE MANUFACTURING PROCESS AND THE DEFECT WOULD HAVE OCCURRED DURING ITS DISTRIBUTION, HANDLING AND/OR STORAGE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A MISASSEMBLED MINICAP FOUND BEFORE USE. THE CUSTOMER REPORTED THAT THE SPONGE WAS NOT IN THE MINICAP WHEN THE POUCH WAS OPENED. THERE WAS NO PATIENT INVOLVEMENT, NOR PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136115 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CUERNAVACA M12J07A

    Patients

    Seq Age Sex Outcome Treatment
    1