FDA Adverse Event
Injury
Summary report: N
CO-AXIAL BREATHING CIRCUIT, ADULT, DISPOSABLE, 2.4 M/96 IN
MDR report key: 15592208
·
Received October 12, 2022
Report
- Report Number
- 3010838917-2022-00015
- Event Type
- Injury
- Date Received
- October 12, 2022
- Date of Event
- September 14, 2022
- Report Date
- September 14, 2022
- Manufacturer
- VYAIRE MEDICAL OY
- Product Code
- CAI
- UDI-DI
- 10190752136908
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO ROOT CAUSE HAS BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 0
IT WAS REPORTED TO VYAIRE MEDICAL THAT THEY NOTICED MINOR LEAKED ON M1152226 - CIRCUIT COAX (A) 2.4M, B.EXT, 2L BAG GSE INTRA-OPERATIVELY. INITIALLY, MACHINE TESTED PASSED WITHOUT LEAK. THEY CHANGED OUT THE CIRCUIT AT THE END OF CASE AND THEY ENCOUNTERED SLIGHT DELAY AS NEW CIRCUIT WAS NEEDED TO BE APPLIED. THE PATIENT WAS STABLE BEFORE AND AFTER THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2566991 | CO-AXIAL BREATHING CIRCUIT, ADULT, DISPOSABLE, 2.4 M/96 IN | ANAESTHESIA BREATHING CIRCUIT, SINGLE-USE | CAI | VYAIRE MEDICAL OY | CIRCUIT COAX (A) 2.4M, B.EXT, 2L BAG GSE | 202746 | 10190752136908 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |