FDA Adverse Event
Other
Summary report: N
INSERTION TRAY
MDR report key: 273259
·
Received April 12, 2000
Report
- Report Number
- 1056436-2000-00071
- Event Type
- Other
- Date Received
- April 12, 2000
- Date of Event
- March 14, 2000
- Report Date
- March 14, 2000
- Manufacturer
- NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC.
- Product Code
- KOC
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON 03/14/2000, THE FACILITY'S MATERIALS MANAGER/SAFETY MANAGER INFORMED THE MANUFACTURER'S (MFR.) REPRESENTATIVE OF THE FOLLOWING: DURING INSERTION, PINHOLE LEAKS WERE FOUND IN THE VENOUS SIDE CATHETER. NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSERTION TRAY | ACUTE POLYURETHANE CATHETER | KOC | NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC. | NA | SE98435 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |