FDA Adverse Event
Other
Summary report: N
V-CATH
MDR report key: 633572
·
Received September 8, 2005
Report
- Report Number
- 2925153-2005-00053
- Event Type
- Other
- Date Received
- September 8, 2005
- Report Date
- September 8, 2005
- Manufacturer
- HDC CORP.
- Product Code
- DQO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
LINE WAS INSERTED, COULD NOT PULL THE SAFE-T-PEEL OTN INTRODUCER SHEATH APART; OTN WING SNAPPED. LINE WAS REMOVED INTACT. PROBLEM WITH THE OTN INTRODUCER NOT THE CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | V-CATH | ACCESS DEVICE | DQO | HDC CORP. | 355-75 | 1074 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |