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, ON MAY 26TH, A PUNCTURE WAS PERFORMED, AND ON THE DAY OF THE EVENT, A CRACK WAS OBSERVED IN THE BLOOD DIALYSIS CATHETER DURING TREATMENT. THAT EVENING AT 7:10 PM, ALL TUBING WAS INSPECTED; NO BLEEDING WAS DETECTED. DURING THE NIGHT SHIFT HANDOVER, A FURTHER EXAMINATION REVEALED BLOOD LEAKAGE ALONG THE CATHETER WALL, AND THE MACHINE WAS SET TO AUTO-CIRCULATION. FURTHER MANAGEMENT WILL BE DETERMINED AFTER PHYSICIAN ASSESSMENT. THE EQUIPMENT WAS CLEANED WITH STANDARD DISINFECTANTS, AND THE LUER ADAPTER WAS CONFIRMED TO BE NORMAL, AND THERE WAS NO ISSUE, RULING OUT EXTERNAL FORCES SUCH AS COMPRESSION. A PERFORATION WAS IDENTIFIED IN THE TRANSPARENT SEGMENT OF THE EXTENSION TUBE, RESULTING IN BLOOD LEAKAGE. AND DIALYSIS WAS CONTINUED. THE AFFECTED PRODUCT WAS REPLACED AS REMEDIAL ACTION AND INTERVENTION. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. BESIDES THE REPORTED ISSUE, THERE WERE NO VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT OUTCOME.