BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT 8.5MM ET TUBE WITH SUBGLOTTIC SUCTIONING

    MDR report key: 3961730 · Received July 28, 2014

    Report

    Report Number
    9611594-2014-00063
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Report Date
    June 30, 2014
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    BTR
    PMA / PMN Number
    PK131254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED COMPLAINT PRODUCT AND REVIEW OF THE DEVICE HISTORY RECORDS ARE IN-PROGRESS. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED. 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. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE AND IDENTIFIED AS (B)(4).

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO REPORTS INVOLVING TWO DEVICES USED DURING THE SAME PROCEDURE ON THE SAME PATIENT. REFER TO MFG REPORT # 9611594-2014-00062 FOR THE FIRST REPORT. KIMBERLY-CLARK RECEIVED A REPORT FROM (B)(6) STATING, "CUSTOMER COMPLAINED THAT THE TUBE TO INFLATE THE CUFF OF OUR MICROCUFF SUBGLOTTIC TUBE COME OFF TWICE AT ONE PATIENT. FIRST THEY THOUGHT THAT THE PATIENT HAS BITTEN THE LINE OFF, BUT AFTER DETAILED INVESTIGATION OF THE CUSTOMER, THEY SAID THAT THIS IS NOT POSSIBLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439351 ADULT 8.5MM ET TUBE WITH SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE BTR KIMBERLY-CLARK HEALTH CARE 13223 AA3260V01

    Patients

    Seq Age Sex Outcome Treatment
    1