FDA Adverse Event
Malfunction
Summary report: N
PER-Q-CATH PLUS A SILICONE PERCUTANEOUS CVC
MDR report key: 1070582
·
Received July 1, 2008
Report
- Report Number
- 3006260740-2008-00025
- Event Type
- Malfunction
- Date Received
- July 1, 2008
- Date of Event
- June 3, 2008
- Report Date
- June 4, 2008
- Manufacturer
- C. R. BARD, INC. (BASD)
- Product Code
- LJS
- PMA / PMN Number
- K954104
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.
Description of Event or Problem · 1
LINE PLACED IN PT. CATHETER SEPARATED FROM THE HUB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PER-Q-CATH PLUS A SILICONE PERCUTANEOUS CVC | LJS | C. R. BARD, INC. (BASD) | RERJ0345 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |