BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 4201631 · Received October 27, 2014

    Report

    Report Number
    1416980-2014-37438
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 9, 2014
    Report Date
    October 1, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS CONDUCTED 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. AN ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED WITH THE NAKED EYE AND A MICROSCOPE, A DAMAGED PATIENT CONNECTOR WAS NOTED. A LEAK TEST AND CLEAR PASSAGE TEST WERE PERFORMED WITH NO ISSUES NOTED. A CLAMP TEST WAS PERFORMED WITH AN ISSUE NOTED UNRELATED TO THE REPORTED PROBLEM. THE REPORTED PROBLEM WAS IDENTIFIED DURING EVALUATION BUT THE CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DAMAGED PATIENT CONNECTOR WAS NOTED ON THE MINICAP TRANSFER SET. 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
    682037 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H13K13063

    Patients

    Seq Age Sex Outcome Treatment
    1