FDA Adverse Event
Malfunction
Summary report: N
TRANSTAR 72 IN DOUBLE MONITORING KIT
MDR report key: 1181937
·
Received September 26, 2008
Report
- Report Number
- 9616567-2008-00081
- Event Type
- Malfunction
- Date Received
- September 26, 2008
- Date of Event
- August 11, 2008
- Report Date
- August 28, 2008
- Manufacturer
- SMITHS MEDICAL, ASD
- Product Code
- DRS
- PMA / PMN Number
- K942377
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER INDICATED THAT SAMPLES WERE UNAVAILABLE FOR RETURN. THE DHR WAS REVIEWED WITH NO ISSUES NOTED. SMITHS WAS UNABLE TO CONFIRM THE ISSUE OR DETERMINE A POSSIBLE CAUSE WITHOUT RETURNED PRODUCT EVALUATION. NO ADDITIONAL ACTION IS NECESSARY AT THIS TIME. SMITHS CONSIDERS THIS MDR CLOSED WITH THIS REPORT.
Description of Event or Problem · 1
THE REPORTER STATED THAT THE POINT OF THE CATHETER AND FLUSH LEAK DURING USE AND CANNOT BE SEALED CAUSING BACKFLOW AND INACCURATE DATA. THERE WERE NO FURTHER DETAILS AVAILABLE AS TO INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRANSTAR 72 IN DOUBLE MONITORING KIT | PRESSURE MONITORING KIT | DRS | SMITHS MEDICAL, ASD | NA | 1278720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |