BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MEDICUS NG ARTERIAL CANNULA

    MDR report key: 21966970 · Received May 6, 2025

    Report

    Report Number
    9612164-2025-02226
    Event Type
    Malfunction
    Date Received
    May 6, 2025
    Date of Event
    April 30, 2025
    Report Date
    May 30, 2025
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    DWF
    UDI-DI
    00763000116088
    PMA / PMN Number
    K142673
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN
    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 REVIEW OF THE EVENT AND/OR ADDITIONAL INFORMATION RECEIVED SHOWS THAT THE FOREIGN MATERIAL WAS OBSERVED ON THE PACKAGING OF THE DEVICE. THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THIS COMPLAINT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS IN 21 CFR 803. 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

    IT WAS REPORTED PRIOR TO USE OF THE BIO-MEDICUS NEXTGEN FEMORAL ARTERIAL OR JUGULAR VENOUS CANNULA, BIOLOGICAL REMAINS WERE OBSERVED ON THE RETURNED DEVICE. THE CANNULA WAS RETURNED FROM THE CENTER TO THE WAREHOUSE. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1884513 BIO-MEDICUS NG ARTERIAL CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO DWF MEDTRONIC MEXICO 96570-117 226872384 00763000116088

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown