MAHURKAR

Description of Event or Problem

ACCORDING TO THE REPORTER, BEFORE USE ON THE PATIENT, DURING PERMEABILITY TESTING, THE EXPIRY DATE AND LOT INFORMATION WERE NOT LEGI BLE, AND THEREFORE IT CANNOT BE DISPENSED TO THE SERVICE. THE REMEDIAL ACTION PERFORMED WAS TO REPLACE THE PRODUCT. THE UNUSUAL THING OBSERVED ON THE DEVICE WAS A CRACK AT THE TIP. THERE WAS NO PATIENT INVOLVEMENT.

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.