BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAMP SHORT NOSE FOR OUTLETPORT

    MDR report key: 1968276 · Received January 23, 2011

    Report

    Report Number
    1423500-2011-00930
    Event Type
    Malfunction
    Date Received
    January 23, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 30, 2010
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    FKK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL SAMPLE WAS RECEIVED AND EVALUATED. THE REPORTED CONDITION WAS CONFIRMED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW WAS NOT CONDUCTED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEMNO ROOT CAUSE RELATING TO THE MANUFACTURING PROCESS HAS BEEN DETERMINED AND NO CORRECTIVE ACTIONS HAVE BEEN IDENTIFIED.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.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) THAT UPON INITIAL USE OF THE CLAMP IT WAS EASILY BROKEN. THE REPORTER WENT THE HOSPITAL TO TEST THE BLUE CLAMP. HE USED NORMAL STRENGTH TO OPEN THE CLAMP AND FOUND 3 CLAMPS WERE BROKEN IN TEN UNITS DURING THE TEST. THERE WAS NO PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED ALONG WITH THIS COMPLAINT. THIS IS REPORT 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLAMP SHORT NOSE FOR OUTLETPORT CLAMP, LINE FKK BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1