BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE, 7.0 MM, ORAL

    MDR report key: 8764370 · Received July 5, 2019

    Report

    Report Number
    9611594-2019-00122
    Event Type
    Malfunction
    Date Received
    July 5, 2019
    Date of Event
    June 12, 2019
    Report Date
    August 30, 2019
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BTR
    UDI-DI
    30680651132209
    PMA / PMN Number
    K131254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ONE UNUSED SAMPLE INSIDE A SEALED PRODUCT PACKAGING WAS RETURNED. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, AA9042V01, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ALL INFORMATION REASONABLY KNOWN AS OF 29-AUG-2019 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). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A HALYARD HEALTH PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 03-JUL-2019 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. 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).

    Description of Event or Problem · 1

    HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 9611594-2019-00123 FOR THE SECOND EVENT. REFER TO 9611594-2019-00124 FOR THE THIRD EVENT. REFER TO 9611594-2019-00125 FOR THE FOURTH EVENT. THE ADAPTER ON THE ENDOTRACHEAL TUBE (ETT) ADAPTER POPPED DURING USE. SOMETIMES THIS OCCURRED WITHIN 20-MINUTES OF THE ETT BEING PLACED. THE RESPIRATORY THERAPISTS WERE TAPING THE ADAPTERS IN PLACE TO PREVENT "POP OFF." THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559114 MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE, 7.0 MM, ORAL VAP MICROCUFF ENDOTRACHEAL TUBES BTR AVANOS MEDICAL INC. 13220 AA9042V01 30680651132209

    Patients

    Seq Age Sex Outcome Treatment
    1