DAR
Received Jun 24, 2026 · Event occurred Apr 3, 2026
Report 9680661-2026-00039 · MDR key 25604668
Device
Product problems
- Filtration Problem
- Material Split, Cut or Torn
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
D10 CONCOMITANT PRODUCT: 300P16002, 300P16002 ADT PP ANAES CIRC EXT 86/270CM, LOT# UNKNOWN. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A LEAK IN THE CIRCUIT AS THE FILTER COMPONENT OF THE ARTIFICIAL NOSE WAS NOT PROPERLY CONSTRUCTED PRIOR TO USE. THERE WAS NO PATIENT INVOLVED. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND A BREAKAGE/HOLE IN THE CIRCUIT.