FDA Adverse Event
Malfunction
Summary report: N
L CATH INTRODUCER
MDR report key: 227646
·
Received June 10, 1999
Report
- Report Number
- 2022441-1999-00007
- Event Type
- Malfunction
- Date Received
- June 10, 1999
- Date of Event
- January 1, 1999
- Report Date
- June 8, 1999
- Manufacturer
- LUTHER MEDICAL PRODUCTS, INC.
- Product Code
- DYB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE NURSE MGR REPORTED THAT WHEN ATTEMPTING TO BREAK AWAY THE T PEEL INTRODUCER, THE WHITE SHEATH PORTION SPLINTERED AND LEFT MIN PIECES ON THE CATHETER ITSELF. THE NURSE HAD TO PICK THE PIECES OF THE INTRODUCER SHEATH OFF OF THE CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | L CATH INTRODUCER | CATHETER INTRODUCER | DYB | LUTHER MEDICAL PRODUCTS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |