BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2142086 · Received June 28, 2011

    Report

    Report Number
    1423500-2011-08421
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 3, 2011
    Manufacturer
    BAXTER HEALTHCARE - SAO PAULO
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A PICTURE OF THE SAMPLE WAS RECEIVED AND THE DAMAGE WAS OBSERVED. THE CAP WAS BROKEN ON THE EDGE. THIS OCCURRED WHILE ON THE EQUIPMENT THAT PERFORMS THE IODINE DOSAGE PUT IN THE CAP. IT WAS DETERMINED THIS WAS CAUSED BY A MANUFACTURING ISSUE. ACCORDING TO MANUFACTURING THIS IS THE FIRST COMPLAINT RECEIVED FOR THIS ISSUE. THE MANUFACTURING FACILITY HAS COMMUNICATED THIS ISSUE TO THEIR PRODUCTION AND QUALITY AREAS. 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). A PICTURE IS AVAILABLE IS AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED. 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.

    Description of Event or Problem · 1

    THIS IS AN INTERNATIONAL REPORT OF A CRACKED/ BROKEN MINICAP. THE PRODUCT HAS NOT BEEN USED ON PATIENTS. 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 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - SAO PAULO PS38F5

    Patients

    Seq Age Sex Outcome Treatment
    1