FDA Adverse Event
Other
Summary report: N
CIRCLE C SILICONE CATHETER KIT
MDR report key: 216016
·
Received March 25, 1999
Report
- Report Number
- 1056436-1999-00052
- Event Type
- Other
- Date Received
- March 25, 1999
- Report Date
- February 25, 1999
- Manufacturer
- NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC.
- Product Code
- FJS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- RADIOLOGIC TECHNOLOGIST
Narratives
Description of Event or Problem · 1
ON 02/25/1999, THE FACILITY'S RADIOLOGY SUPERVISOR INFORMED THE DISTRIBUTOR'S SALES REPRESENTATIVE OF THE FOLLOWING: OVER THE PAST MONTH, THE FACILITY HAS BEEN HAVING PROBLEMS WITH THE EXTENSIONS OF THE CATHETER LEAKING WHEN FLUSHING PRIOR TO INSERTION. THE FACILITY IS REPAIRING THEM IMMEDIATELY AND THEN INSERTING. ACCORDING TO THE RADIOLOGY SUPERVISOR, THE CATHETER EXTENSIONS APPEAR TO HAVE PINHOLES. HE STATED THAT THEY ALSO USE A SIMILAR PRODUCT OF THE MANUFACTURER'S AND HAVE NOT ENCOUNTERED ANY PROBLEMS. IT APPEARS TO BE ISOLATED TO THIS PRODUCT. NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CIRCLE C SILICONE CATHETER KIT | CHRONIC SILICONE CATHETER | FJS | NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC. | NA | VARIOUS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |