BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING TITANIUM ADAPTER

    MDR report key: 3240411 · Received July 22, 2013

    Report

    Report Number
    1416980-2013-19276
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 1, 2013
    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). THE DEVICE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING VISUAL INSPECTION OF THE RETURNED DEVICE, NO ISSUES WERE FOUND. ALSO, NO FAILURES WERE FOUND DURING PERFORMANCE TESTING. THE RETURNED DEVICE MET ALL SPECIFICATIONS. AS A RESULT, THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 4 FOR THIS EVENT. IT WAS REPORTED THAT TITANIUM ADAPTER HAD A SMALL GAP BETWEEN THE UV FLASH TRANSFER SET WHEN THE TWO DEVICES WERE CONNECTED. THIS OCCURRED WITH THREE TRANSFER SETS. THE FOURTH TRANSFER SET WAS ABLE TO CONNECT WITHOUT ANY GAPS. THE TRANSFER SET WAS BEING USED WITH A PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339584 LOCKING TITANIUM ADAPTER SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ KANAE CO.,LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 UV FLASH TRANSFET SET