BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING TITANIUM ADAPTER

    MDR report key: 3172128 · Received June 17, 2013

    Report

    Report Number
    1416980-2013-15494
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 12, 2012
    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 SAMPLE WAS UNAVAILABLE AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT CONNECTOR OF THE TRANSFER SET WOULD NOT CONNECT PROPERLY TO THE TITANIUM ADAPTER WHEN THE CUSTOMER CHANGED THE TRANSFER SET. THE CUSTOMER REPORTED THAT A GAP WAS OBSERVED AT THE JUNCTION. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273924 LOCKING TITANIUM ADAPTER SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ KANAE CO.,LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 TRANSFER SET