D
Patient 1
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL SWIVEL CONNECTOR WAS NOTED TO BE LEAKING.
MAUDE MDR 8510839
- MDR report key
- 8510839
- Report number
- 3012307300-2019-01972
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-03-12
- Date received
- 2019-04-12
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- DAVE HALVERSON
- Address
- 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US
- Phone
- 763-763-7633
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SMITHS MEDICAL SWIVEL CONNECTOR REUSABLE 15MM | CONNECTOR, AIRWAY (EXTENSION) | SMITHS MEDICAL ASD, INC. | BZA | 100/250/001 | 3509428 | N | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-04-12 | 0 |