FDA Adverse Event
Malfunction
Summary report: N
INTERLINK T-CONNECTOR EXTENSION SET
MDR report key: 1240125
·
Received November 24, 2008
Report
- Report Number
- 6000001-2007-05562
- Event Type
- Malfunction
- Date Received
- November 24, 2008
- Date of Event
- April 4, 2007
- Report Date
- April 10, 2007
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 FACILITY CNS INTERN. CUSTOMER REPORTS THAT THE TUBING TO FEMALE LUER CONNECTION SEPARATED 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 T-CONNECTOR EXTENSION SET | INTERLINK EXTENSION SETS | FPA | BAXTER HEALTHCARE CORPORATION | NA | NA01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |