BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAR

    MDR report key: 20061056 · Received August 25, 2024

    Report

    Report Number
    2936999-2024-01367
    Event Type
    Injury
    Date Received
    August 25, 2024
    Date of Event
    June 3, 2024
    Report Date
    December 18, 2024
    Manufacturer
    MALLINCKRODT DAR SRL
    Product Code
    BSY
    UDI-DI
    20884522035207
    PMA / PMN Number
    K031997
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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

    ADDITIONAL INFORMATION: G3, H2 (CORRECTION) CORRECTION: D9, H2 (ADDITIONAL INFORMATION), H6 AND H11 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE CONNECTOR'S MEASUREMENTS WERE INSIDE THEIR SPECIFICATION LIMITS. A LEAKAGE TEST WAS PERFORMED AND FAILED. IT WAS REPORTED THAT THE PATIENT DESATURATED WITH HYPOXIA AS AIR LEAKAGE NOISE BETWEEN THE INTUBATION PROBE AND RESPIRATOR HOSES WAS OBSERVED. THE SUCTION CATHETER WAS REPLACED AND FOUND A CRACKED WHITE TIP FROM THE SIDE OF THE RING FITTING THAT GOES TO THE PIPES OF THE RESPIRATOR. THE REPORTED ISSUE WERE 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

    H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. A LEAKAGE TEST WAS PERFORMED AND FAILED. IT WAS REPORTED THAT THE PATIENT DESATURATED WITH HYPOXIA AS AIR LEAKAGE NOISE BETWEEN THE INTUBATION PROBE AND RESPIRATOR HOSES WAS OBSERVED. THE SUCTION CATHETER WAS REPLACED AND FOUND A CRACKED WHITE TIP FROM THE SIDE OF THE RING FITTING THAT GOES TO THE PIPES OF THE RESPIRATOR. 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.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE PATIENT DESATURATED WITH HYPOXIA AS AIR LEAKAGE NOISE BETWEEN THE INTUBATION PROBE AND RESPIRATOR HOSES WAS OBSERVED. THE SUCTION CATHETER WAS REPLACED AND FOUND A CRACKED WHITE TIP FROM THE SIDE OF THE RING FITTING THAT GOES TO THE PIPES OF THE RESPIRATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480545 DAR CATHETERS, SUCTION, TRACHEOBRONCHIAL BSY MALLINCKRODT DAR SRL 444SP02014 20884522035207

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R