FDA Adverse Event
Malfunction
Summary report: N
MINICAP PD TRANSFER SET (EASY-LOCK) WITH TWIST CLAMP
MDR report key: 1230804
·
Received November 17, 2008
Report
- Report Number
- 1423500-2007-00104
- Event Type
- Malfunction
- Date Received
- November 17, 2008
- Date of Event
- February 8, 2007
- Report Date
- February 8, 2007
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- KDJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
BAXTER PRODUCT SURVEILLANCE RECEIVED NOTIFICATION OF AN INCIDENT FROM THE INTERNATIONAL AFFILIATE IN 2007. BAXTER REPORTED A ROTATOR DEPARTED FROM HOLDER AFTER ABOUT 1 MONTH OF USE. 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 | H06E23112 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |