FDA Adverse Event
Malfunction
Summary report: N
TRANSTAR 84 IN SINGLE MONITORING KIT
MDR report key: 1882481
·
Received October 21, 2010
Report
- Report Number
- 2183502-2010-00465
- Event Type
- Malfunction
- Date Received
- October 21, 2010
- Date of Event
- September 21, 2010
- Report Date
- October 19, 2010
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- DPT
- PMA / PMN Number
- K942377
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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 LEAKED FROM THE STOPCOCK 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 |
|---|---|---|---|---|---|---|---|
| 1 | TRANSTAR 84 IN SINGLE MONITORING KIT | PRESSURE MONITORING SET | DPT | SMITHS MEDICAL ASD, INC. | NA | 1549351 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |