MAHURKAR

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 ONE CATHETER, WITH VISIBLE SIGNS OF USE. FUNCTIONAL TESTING FOUND THAT THE RETURNED DEVICE WAS CLAMPED AND THE VENOUS AND ARTERIAL EXTENSION TUBES WERE FLUSHED WITH WATER. NO LEAKS WERE DETECTED IN THE ARTERIAL LINE, HOWEVER A PIN-HOLE LEAK WAS FOUND IN THE VENOUS EXTENSION TUBE. IT WAS REPORTED THAT THE LUER ADAPTER WAS LEAKING. 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. 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, POSTOPERATIVELY, IT WAS FOUND THAT THE CATHETER HAD BLEEDING (LEAK) AT THE ARTERIAL (RED) LUER ADAPTER. THERE WAS NO CRACK OBSERVED AT THE LUER ADAPTER. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. FLUSHING WAS DONE WITH NORMAL RESULTS. THE CATHETER WAS NOT REPAIRED, AND TEGO WAS NOT UTILIZED. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE, AND NO EXCESSIVE FORCE WAS USED. BY HAND WAS UTILIZED TO TIGHTEN THE ADAPTERS. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE ADAPTER ISSUE. THE CATHETER WAS REPLACED WITH A NEW SET OF CATHETERS AS A REMEDIAL ACTION, AND INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. A BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. THE CATHETER HAD BEEN IN PLACE FOR 1 WEEK. THERE WAS NO REPORTED PATIENT INJURY.

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.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, G3. 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, POSTOPERATIVELY, IT WAS FOUND THAT THE CATHETER HAD BLEEDING (LEAK) AT THE ARTERIAL (RED) LUER ADAPTER. THERE WAS NO CRACK OBSERVED AT THE LUER ADAPTER. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. FLUSHING WAS DONE WITH NORMAL RESULTS. THE CATHETER WAS NOT REPAIRED, AND TEGO WAS NOT UTILIZED. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE, AND NO EXCESSIVE FORCE WAS USED. BY HAND WAS UTILIZED TO TIGHTEN THE ADAPTERS. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE ADAPTER ISSUE. THE CATHETER WAS REPLACED WITH A NEW SET OF CATHETERS AS A REMEDIAL ACTION, AND INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO BLOOD LOSS, BUT JUST A BLOOD LEAK IN THE CATHETER ONLY, AND A BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. THE CATHETER HAS BEEN IN PLACE FOR 1 WEEK. THERE WAS NO REPORTED PATIENT INJURY.