BIO-MEDICUS LIFE SUPPORT TM

Additional Manufacturer Narrative

DEVICE EVALUATION SUMMARY: VISUAL INSPECTION SHOWED THE DEVICE WAS RECEIVED WITH THE OBTURATOR INSERTED INTO THE CANNULA WITH THE TIP PROTRUDING FROM THE CANNULA TIP. ADDITIONAL VISUAL INSPECTION SHOWED THE OBTURATOR WAS DEFORMED INSIDE THE CANNULA. THE OBTURATOR OUTER DIAMETER (OD) WAS MEASURED USING A KEYENCE SCOPE AND THE CANNULA TIP INNER DIAMETER (ID) WAS MEASURED USING A PLUG GAGE. THE CANNULA TIP ID WAS MEASURED, AND IT WAS WITHIN THE SPECIFICATION. THE OBTURATOR OD WAS MEASURED, AND IT WAS WITHIN THE SPECIFICATION. THE OBTURATOR WAS INSERTED AND REMOVED SEVERAL TIMES WITH NO ISSUES NOTED. THE REASON FOR THE RETURN WAS NOT CONFIRMED. CORRECTION B5: MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THREE BIO-MEDICUS NEXTGEN PEDIATRIC ARTERIAL CANNULAE, AND ONE BIO-MEDICUS ARTERIAL LIFE SUPPORT CATHETER, IT WAS REPORTED THAT THE OBTURATORS WERE FEELING "STICKY" IN THE CANNULAE AND THEY WERE NOT GOING IN STRAIGHT. THE CUSTOMER SAID IT FELT LIKE THE OBTURATORS WERE MEETING RESISTANCE AND GETTING DEFORMED. ALL FOUR DEVICES WERE REPLACED, AND THE FINAL CANNULA FELT NORMAL AND WAS USED. 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

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

Additional Manufacturer Narrative

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.