FDA Adverse Event
Malfunction
Summary report: N
5FR POLY PQC
MDR report key: 751958
·
Received July 24, 2006
Report
- Report Number
- 1720496-2006-00218
- Event Type
- Malfunction
- Date Received
- July 24, 2006
- Date of Event
- April 12, 2006
- Report Date
- June 30, 2006
- Manufacturer
- C.R. BARD, INC. (BASD)
- Product Code
- LJS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE HAS BEEN RETURNED TO THE MFR FOR EVAL. THE RESULTS ARE EXPECTED SOON.
Description of Event or Problem · 1
PICC LINE REQUIRED CHANGING IN INTERVENTIONAL RADIOLOGY BECAUSE THE EXISTING PICC'S SUTURE WING TORE AWAY FROM THE PICC LINE DURING THE DRESSING CHANGE WHEN THE OCCLUSIVE DRESSING WAS STUCK TO THE PICC MATERIAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5FR POLY PQC | IMPLANTED LONG TERM INTRAVASCULAR | LJS | C.R. BARD, INC. (BASD) | * | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |