BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MEDICUS NG ARTERIAL CANNULA

    MDR report key: 19359305 · Received May 21, 2024

    Report

    Report Number
    9612164-2024-02433
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Date of Event
    January 25, 2024
    Report Date
    June 6, 2024
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    DWF
    PMA / PMN Number
    K142673
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO B5: MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT BOTH DEVICES WERE USED IN THE SAME CASE AND WERE USED UNTIL THE CONCLUSION OF THE CASE. ADDITIONAL INFO H6: FDC CODE UPDATED 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

    DEVICE EVALUATION SUMMARY: VISUAL INSPECTION SHOWS EVIDENCE OF DAMAGE/CRACK IN THE CONNECTOR. THE HEMOSTASIS CAP WAS NOT RETURNED. REASON FOR RETURN WAS CONFIRMED. 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

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS NEXTGEN FEMORAL BI-CAVAL VENOUS CANNULA KIT, THE CUSTOMER OBSERVED A CRACK ON THE DEVICE. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1427884 BIO-MEDICUS NG ARTERIAL CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO DWF MEDTRONIC MEXICO 96570-117 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown