BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2152015 · Received July 7, 2011

    Report

    Report Number
    1423500-2011-08730
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 13, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER IS UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. THIS COMPLAINT WAS CONFIRMED BY EVALUATION AS CRACKED MINICAPS. THERE IS SUBSTANTIAL FUNCTIONAL TESTING PERFORMED DURING MANUFACTURE TO MONITOR PRODUCT SUSCEPTIBILITY INCLUDING TIGHTENING ON A CONNECTOR AND LEAK TESTING. A KNIT LINE WEAKNESS WHICH CONTRIBUTED TO THIS FAILURE WAS DETECTED. THE CAUSE WAS RELATED TO MANUFACTURING-MOLDING PROCESS. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    AN EMAIL WAS RECEIVED IN THE CORPORATE PRODUCT SURVEILLANCE MAILBOX ON (B)(6) 2011 FROM A PATIENT WHO REPORTED MINICAPS CRACKED IN THE MIDDLE WHILE HE WAS USING THEM. IT HAPPENED TO HIM LAST WEEK AND RN TOLD HIM NOT TO USE THEM. HE STILL HAS 9 MINICAPS LEFT IF BAXTER NEEDS SAMPLES FROM HIM. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THIS IS REPORT 1 OF 2. ON (B)(6) 2011, PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP) REGARDING THE BROKEN MINICAPS. THE HP STATED THEY HAD TWO CAPS THAT BROKE DURING USE AND WAS WILLING TO RETURN THE CAPS. THE HP COULD NOT PROVIDE THE LOT NUMBER TO THE CAPS. THE HP STATED THAT THERAPY HAS BEEN FINE ASIDE FROM THOSE INCIDENTS. THERE WERE NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR HOMECHOICE