BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLET PORT CLAMP

    MDR report key: 2106315 · Received May 28, 2011

    Report

    Report Number
    1423500-2011-06711
    Event Type
    Malfunction
    Date Received
    May 28, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 4, 2011
    Manufacturer
    BAXTER HEALTHCARE ? SWINFORD
    Product Code
    FKK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS NOT CONFIRMED AS NO SAMPLES HAVE BEEN RECEIVED FOR ANALYSIS. A ROOT CAUSE WAS NOT DETERMINED. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW CANNOT BE PERFORMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    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 SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) REPORTED THAT THE CLAMPS BREAK VERY EASILY. A FOLLOW UP WAS DONE VIA PHONE. THE PATIENT STATED THE NEW BOX OF CLAMPS IS WORKING FINE. THE PATIENT WAS INVOLVED BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THIS IS REPORT 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OUTLET PORT CLAMP CLAMP, LINE FKK BAXTER HEALTHCARE ? SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR