BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2950057 · Received February 8, 2013

    Report

    Report Number
    1416980-2013-03242
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 19, 2013
    Manufacturer
    BAXTER HEALTHCARE - CUERNAVACA
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS CONFIRMED DURING EVALUATION OF THE RETURNED SAMPLE AND THE ROOT CAUSE WAS DETERMINED TO BE DUE TO MISHANDLING DURING DISTRIBUTION, HANDLING, OR TIME-OF-USE. A VISUAL INSPECTION WAS PERFORMED AND THE PACKAGING WAS OPEN. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. THE SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. HOWEVER, THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION AS OF YET. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER (B)(6) REGARDING A PACKAGING RELATED ISSUE WITH A MINICAP. THE CUSTOMER STATED THAT THE MINICAP PACKAGING LOOKED CRUSHED AND OPEN. THERE WAS NO PATIENT INVOLVEMENT, PATIENT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54364 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CUERNAVACA M12K25A

    Patients

    Seq Age Sex Outcome Treatment
    1