FDA Adverse Event
Other
Summary report: N
PHERES-FLOW CENTRAL VENOUS CATHETER KIT
MDR report key: 275995
·
Received May 3, 2000
Report
- Report Number
- 1056436-2000-00084
- Event Type
- Other
- Date Received
- May 3, 2000
- Date of Event
- April 4, 2000
- Report Date
- April 4, 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
- UT, US
- Reporter Occupation
- RADIOLOGIC TECHNOLOGIST
Narratives
Description of Event or Problem · 1
ON 04/04/2000, THE FACILITY'S RADIOLOGY TECHNICIAN INFORMED THE MANUFACTURER'S (MFR.) SALES REPRESENTATIVE OF THE FOLLOWING: AS THE PHYSICIAN WAS PUTTING IN THE CATHETER THE CUFF FELL OFF. NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PHERES-FLOW CENTRAL VENOUS CATHETER KIT | CHRONIC SILICONE CATHETER | FJS | NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC. | NA | SE99117 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |