FDA Adverse Event
Malfunction
Summary report: N
CAPD SOLUTION TRANSFER SET (SHORT) FOR UV-FLASH
MDR report key: 318033
·
Received February 23, 2001
Report
- Report Number
- 1423500-2001-00156
- Event Type
- Malfunction
- Date Received
- February 23, 2001
- Date of Event
- January 17, 2001
- Report Date
- January 23, 2001
- Manufacturer
- BAXTER HEALTHCARE CORP.
- Product Code
- KDJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
BAXTER JAPAN REPORTS PINHOLE LEAK IN TUBING AT THE OCCLUDER FEET OF A TRANSFER SET. NO PT INJURY OR MEDICAL INTERVENTION REQUIRED PER AFFILIATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 7519 | CAPD SOLUTION TRANSFER SET (SHORT) FOR UV-FLASH | TRANSFER SET | KDJ | BAXTER HEALTHCARE CORP. | NA | NA01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |