BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3243908 · Received July 23, 2013

    Report

    Report Number
    1416980-2013-19523
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    June 29, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION FOUND THAT THE CAP WAS LOOSE IN THE UNOPENED POUCH. 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED SAMPLE WAS EVALUATED AND CONFIRMED FOR THE REPORTED ISSUE. THE SAMPLE WAS FOUND TO HAVE THE PULL RING CAP THAT HAD SEPARATED FROM THE PATIENT CONNECTOR. THE CAUSE WAS FOUND TO BE MANUFACTURING RELATED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLUE PULL RING OF A MINICAP TRANSFER SET WAS FOUND TO HAVE FALLEN OFF PRIOR TO USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344164 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H13A04047

    Patients

    Seq Age Sex Outcome Treatment
    1