FDA Adverse Event
Other
Summary report: N
CIRCLE C SILICONE CATHETER KIT
MDR report key: 292056
·
Received August 23, 2000
Report
- Report Number
- 1056436-2000-00164
- Event Type
- Other
- Date Received
- August 23, 2000
- Date of Event
- July 22, 2000
- Report Date
- July 25, 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
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IN 2000, THE FACILITY'S ATTENDING NEPHROLOGIST INFORMED THE MFR'S (MFR) SALES REPRESENTATIVE OF THE FOLLOWING: THE CATHETER WAS IMPLANTED IN 2000. IN 2000, DIALYSIS WAS ATTEMPTED AT WHICH TIME SEVERAL TINY HOLES WERE DISCOVERED ON THE BLUE EXTENSION OF THE CATHETER. DIALYSIS WAS STOPPED AND THE CATHETER WAS REMOVED IN 2000. 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 | SE00220 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Other |