BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING TITANIUM ADAPTER

    MDR report key: 3830064 · Received May 23, 2014

    Report

    Report Number
    1416980-2014-16778
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    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 WAS RETURNED TO THE MANUFACTURER AND AN INVESTIGATION WAS PERFORMED. NO PROBLEM WAS FOUND DURING VISUAL INSPECTION. A CONNECTION TEST AND DIMENSIONAL INSPECTION WERE PERFORMED, AND ALL SPECIFICATIONS WERE MET. NO PROBLEM WAS FOUND DURING SAMPLE EVALUATION; THEREFORE, THE REPORTED PROBLEM WAS NOT CONFIRMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LOCKING TITANIUM ADAPTER DID NOT CONNECT WELL TO THE PATIENT CONNECTOR OF A TRANSFER SET. THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308274 LOCKING TITANIUM ADAPTER SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ KANAE CO.,LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 UV FLASH TRANSFER SETS