FDA Adverse Event
Other
Summary report: N
CIRCLE "C" DUAL LUMEN CATHETER (POUCH)
MDR report key: 304592
·
Received November 13, 2000
Report
- Report Number
- 1056436-2000-00223
- Event Type
- Other
- Date Received
- November 13, 2000
- Date of Event
- October 14, 2000
- Report Date
- October 18, 2000
- Manufacturer
- NEOSTAR MEDICAL TECHNOLOGIES / HORIZON MEDICAL PRODUCTS, INC.
- Product Code
- KOC
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE FACILITY'S LEAD BIOMEDICAL ENGINEERING TECH INFORMED THE MFR'S REP OF THE FOLLOWING: A LEAK WAS NOTED IN THE RETURN LUMEN. NO FURTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CIRCLE "C" DUAL LUMEN CATHETER (POUCH) | ACUTE POLYURETHANE CATHETERS | KOC | NEOSTAR MEDICAL TECHNOLOGIES / HORIZON MEDICAL PRODUCTS, INC. | NA | SE00118 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |