BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAR

    MDR report key: 19604779 · Received June 25, 2024

    Report

    Report Number
    2936999-2024-00962
    Event Type
    Malfunction
    Date Received
    June 25, 2024
    Date of Event
    May 27, 2024
    Report Date
    August 22, 2024
    Manufacturer
    MALLINCKRODT DAR SRL
    Product Code
    BSY
    UDI-DI
    20884522035191
    PMA / PMN Number
    K031997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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 DEVICE SHOWED A CRACK IN THE WHITE SWIVEL 15MM CONNECTOR. A LEAKAGE TEST WAS PERFORMED AND IT LEAKED FROM THE CRACK. THE CONNECTORS WERE DIMENSIONALLY INSPECTED AND ALL MEASUREMENTS WERE INSIDE THEIR SPECIFICATION LIMITS. IT WAS REPORTED THAT THE DEVICE HAD AN AIR LEAK OF ABOUT 50ML. THE REPORTED ISSUE WAS 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.

    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.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE HAD AN AIR LEAK OF ABOUT 50ML. THE DISPLAY ON THE VENTILATOR WAS 500ML TIDAL VOLUME OF EXPIRATION (VTE) AND 450ML TIDAL VOLUME OF INSPIRATION (VTI). THE DEVICE WAS REPLACED WITH THE SAME LOT NUMBER. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219157 DAR CATHETERS, SUCTION, TRACHEOBRONCHIAL BSY MALLINCKRODT DAR SRL 444SP02012 21L0525FAX 20884522035191

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown