BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCUFF ADULT ENDOTRACHEAL TUBE

    MDR report key: 10099593 · Received May 28, 2020

    Report

    Report Number
    3011270181-2020-00059
    Event Type
    Malfunction
    Date Received
    May 28, 2020
    Date of Event
    April 30, 2020
    Report Date
    May 28, 2020
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BTR
    UDI-DI
    00609038352169
    PMA / PMN Number
    K113333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 28 MAY 2020 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. 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 · 1

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED NINE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING NINE DIFFERENT PATIENTS. THIS IS THE FIFTH OF NINE REPORTS. REFER TO 3011270181-2020-00055 FOR THE FIRST REPORT. REFER TO 3011270181-2020-00056 FOR THE SECOND REPORT. REFER TO 3011270181-2020-00057 FOR THE THIRD REPORT. REFER TO 3011270181-2020-00058 FOR THE FOURTH REPORT. REFER TO 3011270181-2020-00060 FOR THE SIXTH REPORT. REFER TO 3011270181-2020-00061 FOR THE SEVENTH REPORT. REFER TO 3011270181-2020-00062 FOR THE EIGHTH REPORT. REFER TO 3011270181-2020-00063 FOR THE NINTH REPORT. IT WAS REPORTED THAT "SEVERAL" INCIDENTS OF SUBGLOTTIC ET [ENDOTRACHEAL] TUBE CUFF LEAKS OCCURRED THAT ARE NOTICED VIA CUFF PRESSURE CHECKS "ANYWHERE FROM 2-14 DAYS AFTER INTUBATION." ANESTHESIOLOGIST DOES NOT ALWAYS CHECK ETT [ENDOTRACHEAL TUBE] CUFF PATENCY PRIOR TO INTUBATION. ALL TUBES ARE PLACED VIA VIDEO LARYNGOSCOPE TO CONFIRM CORRECT TUBE PLACEMENT. WHEN CUFF LEAKS ARE NOTICED ALL PATIENTS HAVE REQUIRED REINTUBATION WITHOUT DIFFICULTY. NO PATIENT INJURIES. ADDITIONAL INFORMATION RECEIVED 18-MAY-2020 INCLUDED PATIENT INFORMATION. DATE INTUBATED: (B)(6) 2020, DATE EXTUBATED: (B)(6) 2020. PEEP SETTINGS: 14-16, NO LOT CODE PROVIDED. ADDITIONAL INFORMATION RECEIVED 22-MAY-2020 INDICATED THE PRODUCT WAS NOT ALTERED IN ANY WAY PRIOR TO USE. THE PROBLEM WAS DISCOVERED THROUGH NORMAL PATIENT MONITORING. THE INCIDENT DID NOT OCCUR DURING SURGERY, DID NOT OCCUR DURING TRANSPORT, AND THE PATIENT WAS NOT HAND BAGGED. IT IS UNKNOWN IF THE TUBE MIGRATED. NO ABNORMALITIES WERE NOTED PREVIOUS TO INTUBATION OR RE-INTUBATION. IT IS UNKNOWN HOW MUCH PRESSURE WAS USED TO INFLATE THE BALLOON AND NO PATIENT COMORBIDITY INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561126 MICROCUFF ADULT ENDOTRACHEAL TUBE VAP MICROCUFF ENDOTRACHEAL TUBES BTR AVANOS MEDICAL INC. 35216 UNKNOWN 00609038352169

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR