FDA Adverse Event
Malfunction
Summary report: N
MINIVOLUME EXTENSION SET
MDR report key: 1240285
·
Received November 24, 2008
Report
- Report Number
- 6000001-2007-01425
- Event Type
- Malfunction
- Date Received
- November 24, 2008
- Date of Event
- January 5, 2007
- Report Date
- January 5, 2007
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE HAS BEEN REQUESTED FOR EVALUATION. IF DEVICE IS RECEIVED AND EVALUATED PERFORMED, A FOLLOW-UP MEDWATCH WILL BE FILED.
Description of Event or Problem · 1
BAXTER INTERNATIONAL COORDINATOR ¿ RECEIVED REPORT FROM CUSTOMER ON THIS EXTENSION SET. CUSTOMER REPORTED THE TUBING HAS SEPARATED FROM THE INJECTION SITE. NO PATIENT INJURY HAS BEEN REPORTED AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE ON THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MINIVOLUME EXTENSION SET | EXTENSION SETS | FPA | BAXTER HEALTHCARE CORPORATION | N/A | R05A08055 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |