BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING TITANIUM ADAPTER

    MDR report key: 3162944 · Received June 11, 2013

    Report

    Report Number
    1416980-2013-15002
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    September 26, 2011
    Report Date
    September 30, 2011
    Manufacturer
    KANAE CO.,LTD.
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION OF THE ACTUAL SAMPLE WAS CONDUCTED AND ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE EVALUATION. THERE WAS A GAP BETWEEN THE PATIENT ADAPTOR AND TITANIUM ADAPTOR DURING VISUAL INSPECTION. THE DIMENSION OF THE RETURNED PRODUCT WAS MEASURED AND FOUND THAT THE ACTUAL DIMENSION WAS OUT OF SPECIFICATION. THE LEAK TEST WAS PERFORMED, BUT NO PROBLEM WAS FOUND. THE PROBLEM WAS CONFIRMED AND THE ROOT CAUSE OF THE REPORTED PROBLEM WAS MANUFACTURING MACHINE ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER JAPAN THAT THE TITANIUM ADAPTER COULD NOT BE CONNECTED TO THE PATIENT CONNECTOR COMPLETELY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THERE WAS PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261855 LOCKING TITANIUM ADAPTER SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ KANAE CO.,LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1