FDA Adverse Event
Malfunction
Summary report: N
HOTLINE FLUID WARMING SET
MDR report key: 254465
·
Received December 10, 1999
Report
- Report Number
- 1221261-1999-00012
- Event Type
- Malfunction
- Date Received
- December 10, 1999
- Report Date
- December 10, 1999
- Manufacturer
- SIMS LEVEL 1, INC.
- Product Code
- LGZ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
HOSPITAL REPORTED TO SIMS LEVEL 1 INC SALES REP THAT DURING A PROCEDURE, AN L-70 DISPOSABLE SET HAD BEEN DAMAGED BY A NEEDLE, CAUSING WATER TO IV PATH BREACH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOTLINE FLUID WARMING SET | I.V. FLUID OR BLOOD ADMINISTRATION SET | LGZ | SIMS LEVEL 1, INC. | L-70 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |