BEUDAMED
    FDA Adverse Event Other Summary report: N

    CB-X II DUAL-ENDED CLEANING BRUSH

    MDR report key: 1480109 · Received September 18, 2009

    Report

    Report Number
    8030647-2009-00012
    Event Type
    Other
    Date Received
    September 18, 2009
    Date of Event
    August 19, 2009
    Report Date
    August 19, 2009
    Manufacturer
    AVENT S. DE R.L. DE C.V.
    Product Code
    FEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE HAS NOT BEEN PROVIDED FOR EVALUATION. REVIEW OF PULL TESTS RESULTS IN THE DEVICE HISTORY RECORD FOR THE LOT NUMBER PROVIDED FOUND AN AVERAGE OF 10.17LBS AND A STANDARD DEVIATION OF 0.45LBS, WITH THE LOWEST SPECIFICATION FOR THE ASSEMBLY AT 7LBS. IN ADDITION, SOME CHANGES TO THE MANUFACTURING PROCESS HAVE BEEN IMPLEMENTED SINCE (B)(6) 2009, WHICH INCLUDE THE USE OF A MAGNIFYING GLASS IN THE ASSEMBLY PROCESS AND REINFORCEMENTS OF THE GLUING PROCESS FOR THE TIP TO THE BRUSH. NO ADDITIONAL INFO HAS BEEN RECEIVED. WE WILL CONTINUE TO CLOSELY MONITOR THE FIELD PERFORMANCE OF THIS PRODUCT TO IDENTIFY EMERGING TRENDS AND IF APPLICABLE, ADDITIONAL INVESTIGATIONS AND CORRECTIVE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    KIMBERLY CLARK RECEIVED A COMPLAINT INDICATING THAT "A BROKEN TIP OF A CLEANING BRUSH FELL INTO THE PT". THE PIECE WAS TREATED AS A FOREIGN BODY AND REMOVED DURING THE PROCEDURE. THERE WAS NO HARM REPORTED TO THE PT. NO ADDITIONAL INFO HAS BEEN RECEIVED AT THIS TIME. KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFO THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE AND IDENTIFIED AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CB-X II DUAL-ENDED CLEANING BRUSH ENDOSCOPIC CLEANING BRUSH FEB AVENT S. DE R.L. DE C.V. M9043E302

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention