BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2982521 · Received February 28, 2013

    Report

    Report Number
    1416980-2013-04900
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    BAXTER HEALTHCARE - CALI
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A REPORT OF A MISASSEMBLED MINICAP WAS NOT CONFIRMED. THE SAMPLE WAS UNAVAILABLE, THEREFORE, NO EVALUATION COULD BE PERFORMED AND NO ROOT CAUSE COULD BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A MINICAP IN WHICH THE SPONGE WAS FOUND OUTSIDE OF THE CAP. THERE WAS NO PATIENT INVOLVEMENT AS THE CAP WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88196 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CALI SE12LH0

    Patients

    Seq Age Sex Outcome Treatment
    1