FDA Adverse Event
Malfunction
Summary report: N
MINICAP PD TRANSFER SET (EASY-LOCK) WITH TWIST CLAMP
MDR report key: 1201829
·
Received October 21, 2008
Report
- Report Number
- 1423500-2007-00082
- Event Type
- Malfunction
- Date Received
- October 21, 2008
- Date of Event
- January 24, 2007
- Report Date
- January 25, 2007
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- KDJ
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA ON FEB 20 2007.
Description of Event or Problem · 1
REPORTER REPORTED OCCLUSION IS CLOSED, BUT MINI-SET IS STILL LEAKING. THIS SET HAS BEEN IN USE 5 MONTHS. THE MINI-SET WAS EXCHANGED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS ASSOCIATED WITH THISINCIDENT 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 | H05E16117 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |