MEDTRONIC MINI SUCKER

Additional Manufacturer Narrative

CONTINUATION OF D10: PRODUCT ID 10062 (0231912883); PRODUCT TYPE: 0183-CANNULA; IMPLANT DATE N/A; EXPLANT DATE N/A. 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

MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP RIGID SUCTION TUBE, IT WAS REPORTED THAT THE TIP WAS BLOCKED STRAIGHT OUT OF THE PACKAGE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

Additional Manufacturer Narrative

DEVICE EVALUATION: VISUAL INSPECTION OF THE OPENED DEVICE SHOWS EVIDENCE OF A BLOCKAGE AT THE TIP. THE DEVICE WAS CLEANED USING A 10% BLEACH SOLUTION.PERFORMANCE ANALYSIS: A SYRINGE FILLED WITH DEIONIZED WATER WAS CONNECTED TO THE DEVICE ALONG WITH A PRESSURE GAGE. WHEN THE SYRINGE WAS ENGAGED THERE WAS NO FLOW OBSERVED THROUGH THE DEVICE. CONCLUSION: REASON FOR THE RETURN WAS CONFIRMED. CORRECTION.D.3.MFR.NAME 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.