BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE, ORAL/NASAL MAGILL-5.0-3.5-12

    MDR report key: 19066584 · Received April 8, 2024

    Report

    Report Number
    3011270181-2024-00045
    Event Type
    Injury
    Date Received
    April 8, 2024
    Date of Event
    March 3, 2024
    Report Date
    December 10, 2024
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BTR
    UDI-DI
    00609038351124
    PMA / PMN Number
    K080821
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. ALL INFORMATION REASONABLY KNOWN AS OF 23 APR 2024 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 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

    4650-APPROPRIATE HEALTH IMPACT TERM/CODE NOT AVAILABLE: AUDIBLE BREATH SOUNDS BILATERALLY. THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 04 APR 2024 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 COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT COMP (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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE DOCUMENTED UDI IS BASED ON THE STOCK/PRODUCT CODE PROVIDED BY THE REPORTER; THE UDI-PI IS NOT AVAILABLE AS NO LOT NUMBER WAS PROVIDED FOR THE ALLEGED DEVICE. THE ACTUAL SAMPLE FROM THE REPORTED EVENT WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION OF THE DEVICE: THE SAMPLE WAS RECEIVED WITH THE INFLATION LINE DETACHED AT THE INTERFACE OF THE ENDOTRACHEAL (ETT). THE BODY OF THE ETT DID NOT EXHIBIT DAMAGE AND THE DISCOLORED CUFF WAS ATTACHED. THE INTERFACE AREA WAS EXAMINED UNDER MAGNIFICATION: A SMALL PORTION OF THE INFLATION LINE WAS OBSERVED TO BE INSIDE THE SKIVE ON THE ETT; THE END OF THE INFLATION LINE PIECE WAS EVEN, BUT JAGGED AND THE CORRESPONDING END OF THE DETACHED INFLATION LINE WAS SIMILARLY JAGGED. THE REPORTED EVENT COULD BE CONFIRMED AS REPORTED; HOWEVER, THE ROOT CAUSE IS UNDETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 10 DEC 2024 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 COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT COMP-(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.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE PATIENT EXPERIENCED ACUTE DESATURATION DURING A DIAPER CHANGE; THE EVENT RESOLVED WITH 'PRO RE NATA,' (PRN) SEDATION AND FRACTION OF INSPIRED OXYGEN (FIO2) BOOST. DURING RESUSCITATION, THE RESPIRATORY THERAPISTS (RT) NOTED THE ENDOTRACHEAL (ETT)CUFF PILOT LINE (BALLOON) BECAME DISCONNECTED FROM THE ETT. IT WAS ADDITIONALLY REPORTED, THE PATIENT, WHO WAS ON A PROLONGED INTUBATION COURSE, BECAME VERY AGITATED WITH THE "CARES", (DURING A MORNING DIAPER CHANGE), AND PROGRESSIVELY DESATURATED TO A NADIR OF 9% WITHOUT BRADYCARDIA OR LOSS OF CONSCIOUSNESS AND WITH CYANOSIS, WHICH QUICKLY IMPROVED TO THE 50'S% WITH COMFORT MEASURES AND INCREASED FIO2. [THE] PATIENT RECEIVED MORPHINE AND MIDAZOLAM WHICH SETTLED HIM, AND SATURATIONS RESOLVED TO THE LOW 80S (HIS NORMAL BASELINE). THE RT PERFORMED A LAMBROS'S ASSESSMENT; THE PATIENT REPORTEDLY HAD AUDIBLE BREATH SOUNDS BILATERALLY. THE PRESSURE WAS CHECKED ON THE CUFF OF THE (ETT) AND IT WAS NOTED THE BALLOON ON THE PILOT LINE WAS INFLATED BUT DID NOT APPEAR TO EXPEL AIR AND DEFLATE[D] WHEN SQUEEZED. [DURING THE ASSESSMENT], THE ETT IMMEDIATELY PULLED OUT OF THE PATIENT'S MOUTH. IT WAS REPORTED, THE LINE HAD POTENTIALLY SHEARED AT THE CONNECTION POINT OF THE ETT AND THE BALLOON-LINE. THE MEDICAL DOCTOR(S) WERE NOTIFIED AND DISCUSSED A TUBE EXCHANGE WITH ENT, LIKELY TO BE PERFORMED IN THE OPERATING ROOM [OR] FOR PATIENT SAFETY. IT WAS ADDITIONALLY REPORTED, AN RT, WHO "HAD" THE PATIENT FOR SEVERAL DAYS, STATED THEY HAD BEEN HAVING TO ADD AIR TO THE CUFF TO PREVENT LEAK[AGE], DUE TO AN INTERMITTENTLY, QUIETLY-AUDIBLE CUFF LEAK. ADDITIONAL INFORMATION RECEIVED 20MAR2024 REPORTED, THE ETT WAS PLACED ON (B)(6) 2023 AT 15:09; THERE WERE NO LONG-TERM EFFECTS ON THE PATIENT¿S STATUS, THE ETT WAS CHANGED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411871 MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE, ORAL/NASAL MAGILL-5.0-3.5-12 VAP MICROCUFF ENDOTRACHEAL TUBES BTR AVANOS MEDICAL INC. 35112 UNKNOWN 00609038351124

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Male Required Intervention| O