BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 21420193 · Received February 20, 2025

    Report

    Report Number
    8040459-2025-00020
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    September 6, 2023
    Report Date
    February 20, 2025
    Manufacturer
    KENDALL GAMMATRON, THAILAND
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. D10 CONCOMITANT PRODUCTS: 107-40, 107-40 4.0MM HI CONTOUR 86444 X10 (LOT#:2309133FEN) H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED PRODUCT CODE 107-50 BY COMPARING SPECIFICATION WITH DRAWING NO. GT-54-1426-01 -107-50 (DC00050363 REV A). THE SAMPLE WAS NOT FIND THE BLACK MARK LABEL ON THE INTUBATION PROBE NEAR THE BALLOON WAS MISSING. IT WAS REPORTED THAT THE BLACK MARK LABEL ON THE DEVICE WAS MISSING. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. 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, THE BLACK MARK LABEL ON THE INTUBATION PROBE NEAR THE BALLOON WAS MISSING. REPLACEMENT OF THE TUBE WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088434 MALLINCKRODT AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY CAE KENDALL GAMMATRON, THAILAND 107-50 2303523FEN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11