BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE, 7.5 MM, ORAL

    MDR report key: 7320760 · Received March 7, 2018

    Report

    Report Number
    9611594-2018-00023
    Event Type
    Death
    Date Received
    March 7, 2018
    Date of Event
    February 15, 2018
    Report Date
    March 12, 2018
    Manufacturer
    HALYARD HEALTH
    Product Code
    BTR
    UDI-DI
    30680651132216
    PMA / PMN Number
    K131254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE IS AVAILABLE ALL INFORMATION REASONABLY KNOWN AS OF 03-APR-2018 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. HALYARD HEALTH 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 HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    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. ALL INFORMATION REASONABLY KNOWN AS OF 28-FEB-2018 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. HALYARD HEALTH 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). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2018-00024 FOR THE SECOND EVENT. IT WAS REPORTED THAT A PATIENT'S SUBGLOTTIC ENDOTRACHEAL TUBE (ETT) SUCTION PORT STEM PULLED OUT FROM THE TUBE INTACT AND WAS FOUND IN THE BED WITH THE PATIENT. IT WAS NOTED THAT IT WAS NOT CHEWED OFF BECAUSE THE ENTIRE STEM WAS INTACT. IT WAS BELIEVED THAT IT WAS A MANUFACTURER DEFECT IN HOW THE SUCTION PORT AND STEM ARE JOINED TO THE ETT ADDITIONAL INFORMATION RECEIVED ON 19-FEB-2018 STATED THAT THE PATIENT DIED ON (B)(6) 2018. THE ETT APPEARED TO HAVE BEEN DISCARDED UPON THE PATIENT'S DEATH. IT WAS STATED THAT THE DEATH WAS NOT RELATED TO THE SUCTION LINE SEPARATION. NO FURTHER INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164999 MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE, 7.5 MM, ORAL VAP MICROCUFF ENDOTRACHEAL TUBES BTR HALYARD HEALTH 13221 UNKNOWN 30680651132216

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death