FDA Adverse Event
Malfunction
Summary report: N
MINICAP PD TRANSFER SET (EASY-LOCK) WITH TWIST CLAMP
MDR report key: 1230626
·
Received November 17, 2008
Report
- Report Number
- 1423500-2007-00080
- Event Type
- Malfunction
- Date Received
- November 17, 2008
- Date of Event
- January 30, 2007
- Report Date
- January 30, 2007
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- KDJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SAMPLES WERE NOT AVAILABLE FOR ANALYSIS. RENAL PRODUCT SURVEILLANCE, QUALITY ENGINEERING, ALONG WITH PLANT MANUFACTURING, WILL CONTINUE TO MONITOR THIS PRODUCT LINE.
Description of Event or Problem · 1
BAXTER REPORTED THE INTERNAL LIGHT BLUE OCCLUDER FEET WERE OBSERVED TO BE BROKEN. THEREFORE, THE TRANSFER SET WAS LEAKY AND WAS EXCHANGED. DAMAGE OF THE SET WAS OBSERVED AFTER 4-8 WEEKS AFTER INSTALLING. 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 SET | KDJ | BAXTER HEALTHCARE CORPORATION | NA | H05E16117 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |