BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 3841942 · Received May 31, 2014

    Report

    Report Number
    1416980-2014-17543
    Event Type
    Malfunction
    Date Received
    May 31, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 6, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. A BATCH REVIEW WILL BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED 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. THE DEVICE RECEIVED INTERNAL AND EXTERNAL VISUAL INSPECTION; NO PARTICULATE MATTER WAS IDENTIFIED. THE REPORTED CONDITION WAS UNABLE TO BE VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER IN THE SPONGE OF A MINICAP. THE REPORTER DESCRIBED THE PARTICULATE MATTER AS ¿SHINY STUFF.¿ THIS WAS NOTED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 6 OF 10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320587 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - SWINFORD 13K29H15

    Patients

    Seq Age Sex Outcome Treatment
    1