BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERGUARD

    MDR report key: 20138398 · Received September 4, 2024

    Report

    Report Number
    2936999-2024-01394
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    August 14, 2024
    Report Date
    December 8, 2024
    Manufacturer
    MMJ SA DE CV (USD)
    Product Code
    BTR
    UDI-DI
    10884521620193
    PMA / PMN Number
    K090352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE CUFF PRESENTED A SMALL CUT. FUNCTIONALLY, AN INFLATION/DEFLATION TEST WAS PERFORMED. AIR WAS APPLIED TO THE CUFF USI NG A SYRINGE, AND IT WAS OBSERVED THAT THE CUFF DEFLATED IMMEDIATELY. IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S CUFF WAS DAMAGED. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE WAS DETERMINED TO BE MANUFACTURING RELATED. INTERNAL PROCESS IMPROVEMENTS H AVE BEEN INITIATED TO MITIGATE THIS ISSUE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, PRIOR TO USE, THE ENDOTRACHEAL TUBE'S CUFF WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105427 TAPERGUARD TUBE, TRACHEAL (W/WO CONNECTOR) BTR MMJ SA DE CV (USD) 18775S 23H1428JZX 10884521620193

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown