FDA Adverse Event
Malfunction
Summary report: N
TRANSTAR CATH LAB SET W/1050 4-GANG MANIFOLD
MDR report key: 1003229
·
Received February 21, 2008
Report
- Report Number
- 9616567-2008-00009
- Event Type
- Malfunction
- Date Received
- February 21, 2008
- Date of Event
- January 23, 2008
- Report Date
- January 23, 2008
- Manufacturer
- SMITHS MEDICAL, ASD.
- Product Code
- DRS
- PMA / PMN Number
- K942371
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT HAS BEEN RECEIVED FROM THE CUSTOMER; HOWEVER, SMITHS HAS NOT YET COMPLETED ITS INVESTIGATION INTO THIS ISSUE. A FOLLOW UP REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE REPORTER STATED THAT THERE WAS AIR IN THE LINE--AS IF AIR WAS COMING IN AROUND THE CHECK VALVE. THE LINE AND CONNECTIONS WERE CHECKED. THERE WERE NO HOLES AND THE CONNECTIONS WERE SECURE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY. THE PATIENT EXPERIENCED CHEST PAIN, WHICH WAS SUCCESSFULLY TREATED WITH NITRO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRANSTAR CATH LAB SET W/1050 4-GANG MANIFOLD | PRESSURE MONITORING SET | DRS | SMITHS MEDICAL, ASD. | NA | 1160552 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |