BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMBERLY-CLARK TRACH CARE PRODUCTS

    MDR report key: 1000570 · Received February 15, 2008

    Report

    Report Number
    8030647-2008-00002
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 18, 2008
    Report Date
    February 14, 2008
    Manufacturer
    AVENT S.A. DE C.V.
    Product Code
    BTR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR REQUESTED THE SAMPLE FOR EXAMINATION, BUT THE USER REPORTED THE SAMPLE WAS DISCARDED AND LOT NUMBER WAS UNK. THEREFORE, MFR WAS UNABLE TO PERFORM ADEQUATE INVESTIGATION AS TO THE CAUSE OF THE DISCONNECTION OF THE CATHETER. BASED UPON A SMALL NUMBER OF PREVIOUS COMPLAINTS REGARDING SEPARATION OF THE CATHETER, NONE OF WHICH RESULTED IN INJURY OT THE PT, KIMBERLY-CLARK IMPLEMENTED A CHANGE IN THE MFG PROCESS IN OCTOBER 2007. IN-PROCESS AND LOT RELEASE TESTING OF THE CATHETER BOND TO A MINIMUM STRENGTH REQUIREMENT IS CONDUCTED TO CONFIRM ADEQUATE BONDING. WE WILL CONTINUE TO MONITOR IN-PROCESS AND LOT RELEASE TEST RESULTS AND PROD COMPLAINT TRENDS TO CONFIRM THIS BONDING ISSUE HAS BEEN CORRECTED. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PROD COMPLAINT & MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFO IS USED TO IDENTIFY THE NEED FOR ADD'L INVESTIGATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO THE MFR THAT DURING TRACHEA SUCTIONING PROCEDURE, THE SUCTION CATHETER DISCONNECTED FROM THE VALVE AND REMAINED IN THE ENDOTRACHEAL TUBE. IT WAS REMOVED WITH A CLAMP. THERE WAS NO REPORT OF INJURY OR ADVERSE CONSEQUENCES AS A RESULT OF THE DISCONNECTION. 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 PROD INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIMBERLY-CLARK TRACH CARE PRODUCTS ENDOTRACHEAL TUBE ADAPTERS BTR AVENT S.A. DE C.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1