BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 4123302 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33491
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND AN EVALUATION WAS PERFORMED. A VISUAL INSPECTION WAS PERFORMED AND IT WAS NOTED THAT THE FOAM WAS SEPARATED FROM MINICAP. THE REPORTED ISSUE WAS VERIFIED THROUGH EVALUATION. NO CAUSE WAS ABLE TO BE DETERMINED WITH THE PROVIDED INFORMATION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF THE DEVICE, IT WAS REPORTED THAT THE SPONGE WAS NOTED OUTSIDE OF THE MINICAP. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602851 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - SWINFORD 13J23H15

    Patients

    Seq Age Sex Outcome Treatment
    1