FDA Adverse Event
Malfunction
Summary report: N
INTERLINK CATHETER EXTENSION SET
MDR report key: 1240253
·
Received November 24, 2008
Report
- Report Number
- 6000001-2007-05691
- Event Type
- Malfunction
- Date Received
- November 24, 2008
- Date of Event
- March 11, 2007
- Report Date
- March 19, 2007
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE, SHOULD THE REPORTED DEVICE BE RETURNED AND EVALUATED A FOLLOW UP REPORT WILL BE SUBMITTED. THE CODE REPORTED BY BAXTER WAS LISTED LOT NUMBER S06H18082R. THIS CODE IS MANUFACTURED AND ONLY DISTRIBUTED IN ANOTHER COUNTRY. THIS MEDWATCH WAS FILED FOR THE US CODE, WHICH IS THE SAME AS OR SIMILAR.
Description of Event or Problem · 1
BAXTER REPORTED A COMPLAINT FOR OFF/TUBING-MALE CONNECTOR DURING PATIENT USE. THERE WAS NO REPORTED PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERLINK CATHETER EXTENSION SET | INTERLINK EXTENSION SETS | FPA | BAXTER HEALTHCARE CORPORATION | NA | NA01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |