FDA Adverse Event
Other
Summary report: N
CIRCLE C SILICONE CATHETER KIT
MDR report key: 298360
·
Received September 28, 2000
Report
- Report Number
- 1056436-2000-00198
- Event Type
- Other
- Date Received
- September 28, 2000
- Date of Event
- August 29, 2000
- Report Date
- August 31, 2000
- Manufacturer
- NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC.
- Product Code
- FJS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON 08/31/2000, THE FACILITY'S INTERVENTIONAL RADIOLOGY TECH INFORMED THE DISTRIBUTOR'S SALES MANAGER OF THE FOLLOWING: THE CATHETER WAS PLACED IN THE INTERNAL JUGULAR. UPON FLUSHING THE RED LUMEN, 2 - 3 PINHOLES WERE FOUND. AS A RESULT THE CATHETER WAS REMOVED. NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CIRCLE C SILICONE CATHETER KIT | CHRONIC SILICONE CATHETERS | FJS | NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |