FDA Adverse Event
Malfunction
Summary report: N
V CATH
MDR report key: 401104
·
Received June 19, 2002
Report
- Report Number
- MW1025374
- Event Type
- Malfunction
- Date Received
- June 19, 2002
- Date of Event
- June 16, 2002
- Report Date
- June 18, 2002
- Manufacturer
- HDC CORP
- Product Code
- DQO
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- WA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT IN RESTRAINTS (WRIST) HAD A SITTER IN ROOM WITH THEM. PT MANAGED TO PULL ON PICC AND SEVERED IT 1 CM FROM HUB OF WINGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | V CATH | PICC DUAL LUMEN | DQO | HDC CORP | 395-60 | 1078 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | PICC EXCHANGE DONE. |