CUSTOM TUBING PACK

Additional Manufacturer Narrative

B3: EVENT DATE IS NOT KNOWN. PLEASE SEE B5 FOR APPROXIMATE DATE RANGE, IF APPLICABLE. CONTINUATION OF D10: PRODUCT ID M351104C (232202685); PRODUCT TYPE: 0186-CUSTOM TUBING PACKS; IMPLANT DATE N/A; EXPLANT DATE N/A DEVICE EVALUATION: VISUAL INSPECTION OF THE RETURNED DEVICE SHOWS NO OUTWARD SIGNS OF ANY DAMAGE. THE INFUVALVE, IS DESIGNED TO OPEN AT A LOW PRESSURE OF LESS THAN OR EQUAL TO 15MMHG OR 0.29 PSIG. THE RETURNED DEVICE OPENED AT APPROXIMATELY 670 MMHG / 13 PSI. CONCLUSION: REASON FOR THE RETURN WAS CONFIRMED. 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

MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS CUSTOM TUBING PACK HAD HIGH PRESSURE. THE USE OF THE DEVICE WAS UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.