FDA Adverse Event
Malfunction
Summary report: N
INTERLINK CATHETER EXTENSION SET
MDR report key: 1240183
·
Received November 24, 2008
Report
- Report Number
- 6000001-2007-05834
- Event Type
- Malfunction
- Date Received
- November 24, 2008
- Date of Event
- April 12, 2007
- Report Date
- April 12, 2007
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- 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.
Description of Event or Problem · 1
COMPLAINT RECEIVED FROM BAXTER SALES REP. CUSTOMER REPORTS THAT THE RN TIGHTENED THE CONNECTION BETWEEN THE LUER AND INJECTION SITE, BUT THE CONNECTION CAME LOOSE AND SEPARATED. THERE WAS NO REPORTED PATIENT INJURY OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERLINK CATHETER EXTENSION SET | INTERLINK CATHETER EXTENSION SET | FPA | BAXTER HEALTHCARE CORPORATION | NA | NA01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |