FDA Adverse Event
Malfunction
Summary report: N
TRANSTAR KIDS KIT
MDR report key: 1003227
·
Received February 21, 2008
Report
- Report Number
- 9616567-2008-00011
- Event Type
- Malfunction
- Date Received
- February 21, 2008
- Report Date
- January 24, 2007
- Manufacturer
- SMITHS MEDICAL, ASD INC.
- Product Code
- DRS
- PMA / PMN Number
- K902771
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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 "WHEN THE CLINICIAN IS DRAWING BLOOD FROM THE KIT, AIR IS INTRODUCED INTO THE LINE." THERE WAS NO PATIENT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRANSTAR KIDS KIT | PRESSURE MONITORING KIT | DRS | SMITHS MEDICAL, ASD INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |