BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT 8.0MM ET TUBE WITH SUBGLOTTIC SUCTIONING

    MDR report key: 4173141 · Received October 15, 2014

    Report

    Report Number
    9611594-2014-00122
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    BTR
    PMA / PMN Number
    PK131254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. 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 (B)(4).

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING THE PILOT BALLOON WAS COMPLETELY DISCONNECTED FROM THE ENDOTRACHEAL TUBE. THE PATIENT WAS INTUBATED ON (B)(6) 2014 WITH NO COMPLICATIONS. THE CUFF PRESSURES WERE NOTED BETWEEN 24-28 CM/H2O. THE REGISTERED NURSE TURNED THE PATIENT. WHEN SHE TURNED THE PATIENT BACK OVER THE PILOT LINE WAS OBSERVED LAYING ON THE PATIENT'S BED. THE PATIENT WAS EXTUBATED AND REINTUBATED WITHOUT INCIDENT. NO ADDITIONAL INFORMATION WAS PROVIDED IN REGARDS TO THE PATIENT'S STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655335 ADULT 8.0MM ET TUBE WITH SUBGLOTTIC SUCTIONING ENDORTRACHEAL TUBE BTR KIMBERLY-CLARK HEALTH CARE 13222

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR