BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT 7.0MM ET TUBE WITH SUBGLOTTIC SUCTIONING

    MDR report key: 3853194 · Received June 6, 2014

    Report

    Report Number
    9611594-2014-00042
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 10, 2014
    Report Date
    May 12, 2014
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE UNABLE TO REVIEW THE DEVICE HISTORY RECORD AS NO LOT NUMBER WAS PROVIDED FOR THE DEVICE INVOLVED IN THIS REPORTED EVENT. THE DEVICE WAS NOT RETURNED TO KIMBERLY-CLARK FOR EVALUATION, THEREFORE WE ARE UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED EVENT. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS. DEVICE NOT RETURNED BY CUSTOMER.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, "THE DIRECTOR OF RESPIRATORY REPORTED THAT THE THERAPIST IN THE ICU SAID THAT ALL OF A SUDDEN THE VENTILATOR STARTED TO ALARM . THEY WENT OVER TO THE PATIENT WHO WAS VERY PASSIVE, NOT AGITATED OR MOVING AROUND AND FOUND THE PILOT LINE DISCONNECTED FROM THE TUBE. AS A RESULT THE CUFF HAD DEFLATED. THEY EXTUBATED THE TUBE FROM THE PATIENT. PATIENT WAS IMMEDIATELY RE-INTUBATED WITHOUT INCIDENT. NO INJURY TO PATIENT." KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332733 ADULT 7.0MM ET TUBE WITH SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE BTR KIMBERLY-CLARK HEALTH CARE 13220 ANP

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR