BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMBERLY-CLARK* TRACH CARE PRODUCTS

    MDR report key: 1030426 · Received April 17, 2008

    Report

    Report Number
    8030647-2008-00006
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 20, 2008
    Report Date
    April 16, 2008
    Manufacturer
    AVENT S.A. DE C.V.
    Product Code
    BTR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE WAS NOT RETURNED AND COULD NOT BE EVALUATED. HOWEVER, A FOLLOW-UP REPORT WILL BE PROVIDED IF ADD'L RELEVANT INFO BECOMES AVAILABLE. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT 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

    IT HAS BEEN REPORTED TO THE MANUFACTURER BY THE USER FACILITY THAT THE CATHETER DETACHED FROM UNDER THE THUMB CONTROL VALVE WHEN PRESSED FOR SUCTIONING AND THE PEDIATRIC PT WOULD DESATURATE UPON WITHDRAWAL OF THE CATHETER. AFTER REINSERTION OF THE CATHETER, AGAIN THE STAFF WOULD FEEL THE SLEEVE BECOME SOFT DUE TO THE CATHETER MIGRATING TO THE END OF THE ENDOTRACHEAL TUBE AND CAUSING AN OCCLUSION. IT WAS REPORTED THAT WHILE SUCTIONING THE PT, THE NURSE NOTICED THE PT'S SATURATIONS WERE LOW WITH A STABLE HEARTRATE. THE CATHETER WAS IMMEDIATELY REMOVED FROM THE ENDOTRACHEAL TUBE AND THE NURSE USED HER FINGER TO BLOCK THE PORT. THE PT'S SATURATIONS RETURNED TO NORMAL. THERE WAS NO REPORT OF INJURY OR ADVERSE CONSEQUENCES AS A RESULT OF THE EVENT. 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.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening