BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAP, MINICAP DISCONNECT

    MDR report key: 1972439 · Received January 28, 2011

    Report

    Report Number
    1423500-2011-01169
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - SAO PAULO
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION, HOWEVER, A PICTURE OF THE SAMPLE WAS RECEIVED AND THE REPORTED CONDITION OF CRACK WAS CONFIRMED ON THE CAP. THE CAUSE WAS DETERMINED TO BE MANUFACTURING ISSUE - MOLDING. ICAR WAS OPENED AND THE ROOT CAUSE INVESTIGATION IS CURRENTLY IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). A 510K 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 510K NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME OR SIMILAR TO THE PRODUCT DISTRIBUTED WITHIN THE U.S. SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE CUSTOMER REPORTED 1 UNIT OF MINI CAPS THAT APPEARED DAMAGED. THE PRODUCT LOOKED CRACKED. THE PATIENT WAS CONNECTED TO THE PRODUCT WHEN THE DEFECT WAS OBSERVED. AS A PREVENTATIVE ACTION, THE PATIENT IS BEING ADMINISTERED WITH 250MG EVERY 12 HOURS OF CIPROFLOXACIN. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAP, MINICAP DISCONNECT SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SAO PAULO

    Patients

    Seq Age Sex Outcome Treatment
    1