FDA Adverse Event
Malfunction
Summary report: N
MINICAP PD TRANSFER SET (EASY-LOCK) WITH TWIST CLAMP
MDR report key: 1201859
·
Received October 21, 2008
Report
- Report Number
- 1423500-2007-00078
- 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 16, 2007. BAXTER PRODUCT SURVEILLANCE IS SEEKING ADDITIONAL INFORMATION REGARDING THE AVAILABILITY OF THE SAMPLE. IF THE SAMPLE IS AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE ANALYSIS.
Description of Event or Problem · 1
REPORTER REPORTED THE OCCLUSION IS CLOSED, BUT MINI-SET IS STILL LEAKING AFTER 2 MONTHS IN USE. THE MINI-SET WAS EXCHANGED. 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 | NA01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |