MAHURKAR

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, G3, H6. 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

THE SALES REPRESENTATIVE CONFIRMED THAT THE RETURNED SAMPLE HAD BEEN SENT BY MISTAKE, AND THERE WAS NO ISSUE TO REPORT. THERE WERE NO PROBLEMS OR COMPLAINTS ASSOCIATED WITH THE RETURNED SAMPLE, AS REPORTED BY THE CUSTOMER. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE LUER ADAPTER WAS CRACKED.

Additional Manufacturer Narrative

D10 - CONCOMITANT PRODUCT: 8888145044 PALINDROME H 23/40 KT, 8888145044, LOT: 2326900100 8888135131 13.5FR 13.5CM MAHKA Q+ SEKIT, 8888135131, LOT: 2335200145. 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, AFTER ONE WEEK USAGE OF DIALYSIS, VENOUS (BLUE) END LUER ADAPTER WAS CRACKED AND HAD LEAKED BLOOD. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. NO CLEANING AGENT WAS USED ON THE DEVICE. THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

Description of Event or Problem

ACCORDING TO THE REPORTER, AFTER ONE WEEK OF USAGE OF DIALYSIS, VENOUS (BLUE) END LUER ADAPTERS ON THREE CATHETERS WERE CRACKED AND HAD LEAKED BLOOD. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. NO CLEANING AGENT WAS USED ON THE DEVICE. THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

Additional Manufacturer Narrative

CORRECTION: B5 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

ADDITIONAL INFORMATION: G3, H3, H6. H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. NO INFORMATION RE GARDING THE SPECIFIC CUSTOMER ISSUE THAT OCCURRED WITH THE DEVICE WAS AVAILABLE. UPON EXAMINATION OF THE SAMPLE, IT WAS FOUND THAT THE DEVICE WAS FOUND TO BE CRACKED. A VISUAL INSPECTION OF THE RETURNED DEVICE NOTED TWO CATHETERS, BOTH OF WHICH CONTAINED CRACKS ON THEIR VENOUS LUER ADAPTERS. THE PLACEMENT OF THESE CRACKS SUGGEST THAT THEY WERE CREATED BY THE OVERTIGHTENING OF THE LUER ADAPTERS. OVERTIGHTENING A LUER ADAPTER CAN CAUSE EXCESS STRESS ON IT WHICH CAN LEAD TO CRACKS IN THE MATERIAL. 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. 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.