FDA Adverse Event
Malfunction
Summary report: N
CAPD SOLUTION TRANSFER SET (SHORT ) FOR UV-FLASH
MDR report key: 743597
·
Received July 8, 2005
Report
- Report Number
- 1423500-2005-00965
- Event Type
- Malfunction
- Date Received
- July 8, 2005
- Date of Event
- June 13, 2005
- Report Date
- June 14, 2005
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- KDJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A SAMPLE HAS BEEN REQUESTED FOR EVALUATION.
Description of Event or Problem · 1
BAXTER REPORTS, "A SPIKE OF THE TRANSFER SET WAS BROKEN DURING DRAIN BY Y-SET. THE TRANSFER SET WAS IN PLACE FOR UNK DAYS. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS INCIDENT ACCORDING TO BAXTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPD SOLUTION TRANSFER SET (SHORT ) FOR UV-FLASH | TRANSFER SET | KDJ | BAXTER HEALTHCARE CORPORATION | NA | NA01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |