BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED ETT

    MDR report key: 8274244 · Received January 24, 2019

    Report

    Report Number
    2936999-2019-00076
    Event Type
    Injury
    Date Received
    January 24, 2019
    Date of Event
    December 11, 2018
    Report Date
    April 3, 2019
    Manufacturer
    MMJ SA DE CV (USD)
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: ONE SAMPLE OF THE DEVICE WAS RECEIVED FOR EVALUATION. THE REPORTED EVENT WAS CONFIRMED. AN INFLATION/DEFLATION TEST WAS PERFORMED AND IT WAS OBSERVED THE CUFF DEFLATED IMMEDIATELY. A VISUAL INSPECTION WAS PERFORMED, AND IT WAS OBSERVED THE CUFF PRESENTS A SERIES OF SMALL CUTS. ONCE THE PART IS INSPECTED VISUALLY, THEN THE INSTRUCTION PROVIDES THE GUIDELINES TO DEFLATE THE CUFF. ALL MANUFACTURING CONTROLS WERE FOUND ACCEPTABLE AND EFFECTIVE TO DETECT THE REPORTED FAILURE MODE. INSTRUCTIONS FOR USE (IFU) STATES THAT AS THESE DEVICES MAY HAVE BEEN SUBJECTED TO HANDLING, STORAGE CONDITIONS, OR PREPARATION WHICH COMPROMISED FUNCTIONAL INTEGRITY, EACH TUBE'S CUFF, PILOT BALLOON AND VALVE SHOULD BE TESTED BY INFLATION PRIOR TO USE. IF DYSFUNCTION IS DETECTED IN ANY PART OF THE INFLATION SYSTEM, THE TUBE SHOULD NOT BE USED. INITIATING TREATMENT USING A TUBE ALREADY SHOWN TO HAVE A DYSFUNCTION IN THE INFLATION SYSTEM COULD UNNECESSARILY SUBJECT THE PATIENT TO THE UNTOWARD EFFECTS OF EXTUBATION, REINTUBATION, OR LOSS OF RESPIRATORY SUPPORT. FURTHERMORE, THE INTEGRITY OF THE INFLATION SYSTEM SHOULD BE MONITORED BOTH INITIALLY AND PERIODICALLY DURING THE INTUBATION PERIODS. UNCORRECTED FAILURE OF THE INFLATION SYSTEM COULD RESULT IN DEATH. VARIOUS BONY ANATOMICAL STRUCTURES (E.G., TEETH, TURBINATES) WITHIN THE INTUBATION ROUTES OR ANY INTUBATION TOOLS WITH SHARP SURFACES PRESENT A THREAT TO MAINTAINING CUFF INTEGRITY. CARE MUST BE TAKEN TO AVOID DAMAGING THE THIN-WALLED CUFFS DURING INSERTION WHICH WOULD CREATE THE NEED TO SUBJECT THE PATIENT TO THE TRAUMA OF EXTUBATION AND REINTUBATION. IF CUFF IS DAMAGED, THE TUBE SHOULD NOT BE USED. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO DISCREPANCIES WERE FOUND. INFORMATION HAS BEEN ADDED TO THE DATABASE AND TRENDS WILL CONTINUE TO BE MONITORED. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE DEVICE'S CUFF HAD DEFLATION ISSUE. THE CUSTOMER REPORTED THAT PATIENT REQUIRED RE-INTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68406 UNSPECIFIED ETT TUBE, TRACHEAL (W/WO CONNECTOR) BTR MMJ SA DE CV (USD) UNSPECIFIED ETT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention