FDA Adverse Event
Malfunction
Summary report: N
INTERLINK I.V. CONN LOOP/MALE LUER SLIP ADAPTER
MDR report key: 1240290
·
Received November 24, 2008
Report
- Report Number
- 6000001-2007-01748
- Event Type
- Malfunction
- Date Received
- November 24, 2008
- Date of Event
- January 1, 2007
- Report Date
- January 16, 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 ANOTHER COUNTRY'S CO WAS LISTED AS LOT NUMBER S06G06105R. THIS CODE IS MANUFACTURED IN ANOTHER COUNTRY, AND ONLY DISTRIBUTED IN OTHER COUNTRY. THIS MEDWATCH WAS FILED FOR THE US, WHICH IS THE SAME AS OR SIMILAR.
Description of Event or Problem · 1
INTERNATIONAL COMPLAINT RECEIVED. CUSTOMER REPORTS ¿LEAK/TUBING-FEMALE CONNECTOR¿ DURING PRIMING. 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 I.V. CONN LOOP/MALE LUER SLIP ADAPTER | INTERLINK EXTENSION SETS | FPA | BAXTER HEALTHCARE CORPORATION | NA | NA01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |