N
Patient 1
IT HAS BEEN INDICATED THAT USED AND UNUSED DEVICE SAMPLES WILL BE RETURNED FOR EVALUATION, HOWEVER THEY HAVE NOT YET ARRIVED. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. ((B)(4)).
MAUDE MDR 8623260
- MDR report key
- 8623260
- Report number
- 1317056-2019-00067
- Event key
- 0
- Event type
- 3
- Date received
- 2019-05-20
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 3
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. LAW RYAN
- Address
- 10 GLENS FALLS TECHNICAL PARK GLENS FALLS NY 12801 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ANGIODYNAMICS | CARDIOVASCULAR PROCEUDRE KIT | ANGIODYNAMICS | OEZ | H965601910111 | 5450161 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-05-20 | 0 |
Event Narratives#
D
Patient 1
AS REPORTED, WITH A CONVENIENCE KIT, AIR BUBBLES WERE BELIEVED TO BE ENTERING THE LINE AT THE CONNECTION OF THE DISPOSABLE TRANSDUCER AND THE PRESSURE MONITORING LINE. "THE CONNECTIONS WERE THEN TIGHTENED, AND EVENTUALLY CHANGED OUT." NO AIR WAS INJECTED AND THERE WAS NO PATIENT INJURY. SAMPLES ARE BEING RETURNED TO ANGIODYNAMICS FOR EVALUATION.