FDA Adverse Event
Malfunction
Summary report: N
ULTRA FOUR-WAY STOPCOCK W/SWIVEL MALE LUER LOCK
MDR report key: 3173219
·
Received June 6, 2013
Report
- Report Number
- 2183502-2013-00300
- Event Type
- Malfunction
- Date Received
- June 6, 2013
- Date of Event
- May 4, 2013
- Report Date
- June 5, 2013
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FMG
- PMA / PMN Number
- PREAMENDMENT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- 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
THE REPORTER STATED THAT THE DEVICE BECAME DISASSEMBLED DURING USE. THERE WAS NO REPORTED PATIENT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 251890 | ULTRA FOUR-WAY STOPCOCK W/SWIVEL MALE LUER LOCK | STOPCOCKS AND MANIFOLDS | FMG | SMITHS MEDICAL ASD, INC. | NA | 2401459 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |