MAHURKAR

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.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, IT WAS FOUND THAT THE CATHETER'S VENOUS END CONNECTOR WAS BLEEDING. IT WAS STATED THAT THERE WAS A LEAK AT THE LUER ADAPTER. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE WITH NORMAL RESULTS. THE CATHETER WAS NOT REPAIRED. THERE WAS NO ISSUE WITH THE AND NO CRACK WAS OBSERVED AT THE LUER ADAPTER. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. ASIDE FROM THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE CATHETER NEEDED TO BE REPLACED. AS A REMEDIAL ACTION, THE CATHETER WAS REPLACED. THE TREATMENT PROCEEDED AND WAS COMPLETED AFTER THE REMEDIAL ACTION WAS DONE. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A R ESULT OF THE EVENT. THERE WAS NO BLOOD LOSS, AND A BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

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 THAT ONE CATHETER, WITH ITS VENOUS LUER ADAPTER PULLED 1 CENTIMETER OUT FROM THE VENOUS EXTENSION LINE. THE CATHETER WAS THEN FLUSHED, AND WATER APPEARED TO LEAK FROM THE LOCATION THAT THE EXTENSION LINE MET THE PULLED ADAPTER. IT IS UNCLEAR IF THE ADAPTER WAS PULLED BY THE USER OR IF THE OBSERVED CONDITION WAS PRESENT WHEN THE USER OPENED THE CATHETER KIT. IT WAS REPORTED THAT THE LUER ADAPTER WAS LEAKING. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. 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.