FDA Adverse Event
Injury
Summary report: N
ULTRA FOUR-WAY STOPCOCK W/SWIVEL MALE LUER LOCK
MDR report key: 2071613
·
Received April 20, 2011
Report
- Report Number
- 2183502-2011-00155
- Event Type
- Injury
- Date Received
- April 20, 2011
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FMG
- PMA / PMN Number
- K820355
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.
Description of Event or Problem · 1
.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRA FOUR-WAY STOPCOCK W/SWIVEL MALE LUER LOCK | STOPCOCKS AND MANIFOLDS | FMG | SMITHS MEDICAL ASD, INC. | NA | 1798973 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |