BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE, 8.0 MM, ORAL

    MDR report key: 7194192 · Received January 16, 2018

    Report

    Report Number
    9611594-2018-00002
    Event Type
    Death
    Date Received
    January 16, 2018
    Date of Event
    December 26, 2017
    Report Date
    January 18, 2018
    Manufacturer
    HALYARD HEALTH
    Product Code
    BTR
    UDI-DI
    10680651132229
    PMA / PMN Number
    K131254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION REASONABLY KNOWN AS OF 05 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).

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 12 JAN 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).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 18 JAN 2018: ANSWERS TO QUESTIONNAIRE: HOW LONG AFTER THE MALFUNCTION DID THE PATIENT¿S DEATH OCCUR? "CPR IN PROGRESS BEFORE EVENT. DEATH 15 MINUTES OF ARRIVAL FROM ADMISSION." DATE OF DEATH: (B)(6) 2017. DO YOU BELIEVE THE PRODUCT MALFUNCTION CONTRIBUTE TO PATIENT DEATH? PLEASE EXPLAIN: "NO, PATIENT SUCCUMBED TO HIS TRAUMATIC INJURIES EXTERNAL OF HOSPITAL."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TREATMENT FOR PATIENT TRAUMA ARREST, THE BLUE ENDOTRACHEAL TUBE (ETT) ADAPTER REPEATEDLY CAME LOOSE FROM THE ETT. THE PATIENT HAD VOMITED AND MADE THE ADAPTER SLICK AND DIFFICULT TO KEEP IN PLACE. PER THE REPORTER, "THE ADAPTER CAME LOOSE MORE TIMES THAN I COULD COUNT DURING THE RESUSCITATION." ALSO THE REPORTER STATED THAT THEIR GLOVES HAD BECOME COATED IN VOMIT, CAUSING EVERYTHING THEY TOUCHED TO ALSO BE COATED IN VOMIT AND BECOME SLICK AND DIFFICULT TO MANAGE, INCLUDING THE TUBE HOLDER, SPO2 HOLDER, ETC. PER ADDITIONAL INFORMATION RECEIVED 5 JAN 2018, THIS OCCURRED DURING INTUBATION OF THE PATIENT. THE REPORTER IS NOT SURE IF THE RESIDENT WHO PERFORMED THE INTUBATION PRESSED THE BLUE PIECE INTO THE ETT AS PER THE INSTRUCTIONS FOR USE. THE REPORTER WAS UNSURE IF PRESSING IN THE CONNECTOR IS PART OF THE TRAINING FOR THOSE THAT PERFORM INTUBATIONS AT THE HOSPITAL. IT WAS REPORTED THAT TO RESOLVE THE ISSUE, SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO FIRMLY PRESS IN THE ADAPTER. THE REPORTER WAS UNSURE IF THE PATIENT WAS INJURED AS A RESULT OF THE INCIDENT, AS THE PATIENT "SUCCUMBED TO OTHER INJURIES." DATE OF DEATH WAS NOT PROVIDED. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39222 MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE, 8.0 MM, ORAL VAP MICROCUFF ENDOTRACHEAL TUBES BTR HALYARD HEALTH 13222 UNKNOWN 10680651132229

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death