FDA Adverse Event
Malfunction
Summary report: N
TESIO-GENERAL
MDR report key: 382015
·
Received March 8, 2002
Report
- Report Number
- 2518902-2002-00038
- Event Type
- Malfunction
- Date Received
- March 8, 2002
- Date of Event
- February 9, 2002
- Report Date
- February 20, 2002
- Manufacturer
- MEDCOMP MEDICAL COMPONENTS, INC
- Product Code
- LFJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
Narratives
Description of Event or Problem · 1
ARTERIAL LUMEN HAD A SLIT IN IT. EXTENSION HAD TO BE CHANGED. THE PT WAS SENT TO THE ER, WAS RELEASED AND THE NEXT DAY HAD THE EXTENSION CHANGED. THE NURSE STATED THAT THE LUMEN COULD HAVE BEEN WEAKENED FROM TAPING THE LUMENS TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TESIO-GENERAL | HEMODIALYSIS CATHETER | LFJ | MEDCOMP MEDICAL COMPONENTS, INC | 106* | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |