BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLET USED TO ASSESS PATENCY AND KINKING STOPPED IN THE BACK OF THE MOUTH.

    MDR report key: 13021345 · Received December 16, 2021

    Report

    Report Number
    3011270181-2021-00060
    Event Type
    Injury
    Date Received
    December 16, 2021
    Report Date
    December 16, 2021
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BTR
    UDI-DI
    00609038351186
    PMA / PMN Number
    K080821
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 16-DEC-2021 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).

    Description of Event or Problem · 0

    AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3011270181-2021-00058 FOR THE FIRST EVENT. REFER TO 3011270181-2021-00059 FOR THE SECOND EVENT. IT WAS REPORTED THE PATIENT EXPERIENCED POOR VENTILATION AFTER INTUBATION. THE ETT WAS ADVANCED FROM 22 TO 25 WITH NO CHANGES NOTED ON THE X-RAY. THERE WAS DIFFICULTY SUCTIONING THE PATIENT AND PASSING THE SUCTION CATHETER THROUGH THE MICROCUFF ENDOTRACHEAL TUBE (ETT). THE CLINICIANS REINSERTED THE STYLET TO ASSESS PATENCY AND THE DEVICE WOULD NOT ADVANCE PAST THE ETT SECTION IN THE BACK OF THE PATIENT'S MOUTH. THE DEVICE WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1914556 STYLET USED TO ASSESS PATENCY AND KINKING STOPPED IN THE BACK OF THE MOUTH. VAP MICROCUFF ENDOTRACHEAL TUBES BTR AVANOS MEDICAL INC. 35118 UNKNOWN 00609038351186

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male Required Intervention