FDA Adverse Event
Malfunction
Summary report: N
V-CATH
MDR report key: 382126
·
Received March 13, 2002
Report
- Report Number
- MW1024369
- Event Type
- Malfunction
- Date Received
- March 13, 2002
- Date of Event
- March 12, 2002
- Report Date
- March 12, 2002
- Manufacturer
- HDC CORP
- Product Code
- DQO
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE 395-50 5.0 FR DUAL LUMEN PICC LOT 1065 FOUND TO HAVE A "TAG" LIKE PROJECTION NEAR THE PROXIMAL LUMEN. ANOTHER PRODUCT WAS USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | V-CATH | PICC | DQO | HDC CORP | 395 50 | 1065 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR |