BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2165124 · Received July 17, 2011

    Report

    Report Number
    1423500-2011-09126
    Event Type
    Malfunction
    Date Received
    July 17, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 21, 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). A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME OR SIMILAR TO THE PRODUCT DISTRIBUTED WITHIN THE U.S. THE SAMPLE HAS BEEN RECEIVED AT BAXTER FOR EVALUATION. HOWEVER, THE EVALUATION IS NOT COMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE FILED SHOULD ANY SIGNIFICANT SUPPLEMENTAL INFORMATION BECOME AVAILABLE

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: THE SAMPLE WAS ACTUALLY NOT RETURNED TO BAXTER INTERNATIONAL INC. THIS PRODUCT IS MADE BY A THIRD PARTY MANUFACTURER. A EVALUATION WAS DONE BY THE THIRD PARTY. NO DEFECT WAS FOUND VISUALLY OR DIMENSIONALLY. THIS COMPLAINT WAS NOT ATTRIBUTED TO USER ERROR.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TO REPORT THAT THE PATIENT CONNECTOR WAS UNEXPECTEDLY SEPARATED FROM THE (TITANIUM) CATHETER ADAPTER. THE SET HAD BEEN USED FOR 1 DAY. THE CATHETER ADAPTER HAD BEEN USED FOR 1 DAY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THERE WAS PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ KANAE CO., LTD. 01023 OR 01124

    Patients

    Seq Age Sex Outcome Treatment
    1 TRANSFER SET