BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE, ORAL/NSL

    MDR report key: 16860023 · Received May 3, 2023

    Report

    Report Number
    3011270181-2023-00041
    Event Type
    Malfunction
    Date Received
    May 3, 2023
    Report Date
    November 6, 2023
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BTR
    UDI-DI
    10680651351132
    PMA / PMN Number
    K080821
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 02-MAY-2023 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 AVANOS MEDICAL, INC. 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 AVANOS MEDICAL, INC. AVANOS MEDICAL, INC. 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 AVANOS MEDICAL, INC. 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 AN AVANOS MEDICAL, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED. THE INCIDENT INVESTIGATION WAS PERFORMED BASED ON THE CONTENT OF THE ISSUE REPORTED. BASED ON THE FAILURE ANALYSIS LAB EVALUATION, THE SAMPLE WAS NOT RETURNED WITH THE ORIGINAL PACKAGING. NO OTHER COMPONENTS RECEIVED. THERE WERE NO RETURNED PARTS OF THE PILOT BALLOON PILLOW. THE RETURNED DEVICE WAS EXAMINED UNDER MAGNIFICATION. THERE WERE PARTIAL DEPTH MARKING ON THE INFLATION TUBING. NO VISIBLE JAGGED BREAKAGE AT THE TIP OF THE INFLATION TUBING WHERE THE PILOT BALLOON PILLOW WAS LOCATED. NO VISIBLE BREAKAGE AT THE CONNECTION POINT OF INFLATION LINE. SINCE THERE WAS NO PILOT BALLOON PILLOW RETURNED WITH THE DEVICE, THE INFLATION LINE WAS INFLATED WITH AIR USING AN EVALUATION DEVICE TIP AND SYRINGE, THE BALLOON CUFF DID NOT APPEAR TO BE BURST OR DAMAGED. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 03-NOV-2023 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 AVANOS MEDICAL, INC. 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 AVANOS MEDICAL, INC. AVANOS MEDICAL, INC. 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 AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(6). 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 AN AVANOS MEDICAL, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED "AIR LEAKAGE OCCURRED DURING USE [OF THE ENDOTRACHEAL TUBE]. WHEN CHECKED ITS APPEARANCE, INFLATION VALVE AND PILOT BALLOON DETACHED." THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628837 MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE, ORAL/NSL VAP MICROCUFF ENDOTRACHEAL TUBES BTR AVANOS MEDICAL INC. 35113 UNKNOWN 10680651351132

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown