FDA Adverse Event
Malfunction
Summary report: N
INTERLINK CATHETER EXTENSION SET/MALE LUER
MDR report key: 1240246
·
Received November 24, 2008
Report
- Report Number
- 6000001-2007-05634
- Event Type
- Malfunction
- Date Received
- November 24, 2008
- Date of Event
- April 2, 2007
- Report Date
- April 11, 2007
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RETURN OF THE ACTUAL DEVICE FOR EVALUATION WAS REQUESTED. SHOULD THE SAMPLE BECOME AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF TESTING. THE MANUFACTURING FACILITY HAS BEEN MADE AWARE OF THIS REPORT THROUGH BAXTER'S COMPLAINT MANAGEMENT TRACKING SYSTEM. THE MANUFACTURING FACILITY WILL CONTINUE TO MONITOR SIMILAR REPORTS FOR POSSIBLE TRENDS.
Description of Event or Problem · 1
INTERNATIONAL COMPLAINT RECEIVED. CUSTOMER REPORTS LEAK OF MULTIPLE VITAMIN DURING PATIENT USE. NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERLINK CATHETER EXTENSION SET/MALE LUER | INTERLINK EXTENSION SETS | FPA | BAXTER HEALTHCARE | NA | NA 01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | MULTIPLE VITAMIN. |