FDA Adverse Event
Other
Summary report: N
CIRCLE C SILICONE CATHETER KIT
MDR report key: 242295
·
Received September 28, 1999
Report
- Report Number
- 1056436-1999-00166
- Event Type
- Other
- Date Received
- September 28, 1999
- Date of Event
- September 8, 1999
- Report Date
- September 9, 1999
- Manufacturer
- HORIZON MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC.
- Product Code
- LFJ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
ON 09/09/1999, THE FACILITY'S RN, RADIOLOGY SUPERVISOR INFORMED THE MANUFACTURER'S (MFR) SALES REP OF THE FOLLOWING: THE CATHETER WAS INSERTED AND THEN BLOOD RETURNED WAS CHECKED. THE RED RETURN WAS SEEN TO HAVE A SMALL HOLE IN THE EXTENSION. NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CIRCLE C SILICONE CATHETER KIT Implant | CHRONIC SILICONE CATHETER | LFJ | HORIZON MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC. | NA | SE99060 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |