BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET

    MDR report key: 2202665 · Received August 11, 2011

    Report

    Report Number
    1423500-2011-10590
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 22, 2011
    Manufacturer
    BAXTER HEALTHCARE - CALI
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE OF A PARTICLE EMBEDDED IN THE SPIKE CONNECTOR WAS CONFIRMED. THE CAUSE WAS DETERMINED TO BE RESIDUE FROM A GLOVE USED IN THE MOLDING AREA. AS A PREVENTIVE ACTION, THE GLOVE MATERIAL WILL BE CHANGED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A NURSE REPORTED TO BAXTER AN ISSUE OF A DEAD INSECT EMBEDDED IN A SPIKE CONNECTER OF A HOMECHOICE DISPOSABLE SET. THE NURSE STATED THAT THEY OPENED A POUCH AND FOUND A PARTICLE THAT LOOKED LIKE A DEAD INSECT EMBEDDED IN THE SPIKE CONNECTOR. THE SAMPLE WAS AVAILABLE. THE PRODUCT WAS NOT USED ON ANY PATIENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - CALI SE10JC7

    Patients

    Seq Age Sex Outcome Treatment
    1