SHILEY

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, G3, H3, H6. H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED NO SIGN OF DEFECT. EXAMINATION OF THE CUFF BODY USING THE MICROVU SHOWS A SURFACE SLIT THAT MEASURES 2.4 MM IN LENGTH. THIS TYPE OF DAMAGE IS INDICATIVE OF THE CUFF BODY COMING IN CONTACT WITH A SHARP UTENSIL OR OBJECT. IT WAS REPORTED THAT DURING PRE-USAGE TESTING, THREE DOUBLE-LUMEN AND AN ENDOTRACHEAL TUBE'S CUFF EACH HAD AN INFLATION OR DEFLATION ISSUES. THE REPORTED ISSUE WAS CONFIRMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. THE INSTRUCTIONS INCLUDED WITH THIS DEVICE PROVIDE THE FOLLOWING GUIDANCE: SYRINGES, THREE-WAY STOPCOCKS OR OTHER LUER TIP DEVICES SHOULD NOT BE LEFT INSERTED IN THE INFLATION VALVES FOR EXTENDED PERIODS OF TIME. 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

IT WAS REPORTED THAT DURING PRE-USAGE TESTING, THREE DOUBLE-LUMEN AND AN ENDOTRACHEAL TUBE'S CUFF EACH HAD AN INFLATION OR DEFLATION ISSUES. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

D10 CONCOMITANT PRODUCT: 125037 37FR LT BRONCO CATH PU CUFF X1 LOT: 202407081X 125035 35FR LT BRONCO CATH PU CUFF X1 LOT: 202408099X 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.