FDA Adverse Event
Malfunction
Summary report: N
8" CATHETER EXTENSION
MDR report key: 13861
·
Received March 21, 1994
Report
- Report Number
- 2243621-1994-08004
- Event Type
- Malfunction
- Date Received
- March 21, 1994
- Report Date
- February 17, 1994
- Manufacturer
- FRESENIUSS USA, INC
- Product Code
- FKY
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- NC, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
FACILITY ALLEGES CRACK WAS NOTICED IN CONNEECTOR OF 8" CATH EXTENSION, DURING DRAINAGE, BY PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 8" CATHETER EXTENSION | CONNECTOR SITE TUBING | FKY | FRESENIUSS USA, INC | 4330288 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |