FDA Adverse Event
Death
Summary report: N
CIRCLE "C" DUAL LUMEN CATHETER KIT
MDR report key: 426526
·
Received November 8, 2002
Report
- Report Number
- 1056436-2002-00145
- Event Type
- Death
- Date Received
- November 8, 2002
- Report Date
- November 8, 2002
- Manufacturer
- HORIZON MEDICAL PRODUCTS, INC.
- Product Code
- KOC
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IN 2002, THE INTERNATIONAL REPRESENTATIVE RECEIVED THE FOLLOWING INFORMATION FROM THE INTERNATIONAL DISTRIBUTOR: EMERGENCY SURGERY PRIOR TO PATIENT'S DEATH REVEALED THAT A PERFORATION INJURY HAD BEEN SUSTAINED AT THE JUNCTION OF THE LEFT SUBCLAVIAN AND INTERNAL JUGULAR VEINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CIRCLE "C" DUAL LUMEN CATHETER KIT | ACUTE CATHETERS | KOC | HORIZON MEDICAL PRODUCTS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death |