FDA Adverse Event
Malfunction
Summary report: N
MINICAP PD TRANSFER SET (EASY-LOCK) WITH TWIST CLAMP
MDR report key: 1230889
·
Received November 17, 2008
Report
- Report Number
- 1423500-2007-00072
- Event Type
- Malfunction
- Date Received
- November 17, 2008
- Date of Event
- December 19, 2006
- Report Date
- December 20, 2006
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- KDJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
BAXTER PRODUCT SURVEILLANCE RECEIVED NOTIFICATION OF AN INCIDENT FROM THE INTERNATIONAL AFFILIATE IN 2006. BAXTER REPORTED LEAKAGE AROUND THE CLAMP. THE SAMPLE IS AVAILABLE AND HAS BEEN REQUESTED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS ASSOCIATED WITH THIS INCIDENT PER THE INTERNATIONAL AFFILIATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MINICAP PD TRANSFER SET (EASY-LOCK) WITH TWIST CLAMP | MINICAP TRANSFER SETS | KDJ | BAXTER HEALTHCARE CORPORATION | NA | NA01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |