FDA Adverse Event
Other
Summary report: N
CIRCLE C SILICONE CATHETER KIT
MDR report key: 232891
·
Received July 23, 1999
Report
- Report Number
- 1056436-1999-00127
- Event Type
- Other
- Date Received
- July 23, 1999
- Date of Event
- June 25, 1999
- Report Date
- June 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
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON 6/25/1999, THE FACILITY'S RADIOLOGY TEAM LEADER INFORMED THE MANUFACTURER'S (MFR.) SALES REP OF THE FOLLOWING: PRIOR TO IMPLANT, TWO (2) 28 CM CATHETERS WERE FLUSHED AND SMALL HOLES APPEARED WHERE THE FLUSH WAS LEAVING THE CATHETERS. THIS REPORT CONCERNS THE FIRST CATHETER. REFERENCE MDR# 1056436-1999-00128 FOR THE REPORT ON THE SECOND CATHETER. 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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |