FDA Adverse Event
Malfunction
Summary report: N
MINICAP PREP KIT JAPAN
MDR report key: 1934033
·
Received December 21, 2010
Report
- Report Number
- 1423500-2010-07114
- Event Type
- Malfunction
- Date Received
- December 21, 2010
- Date of Event
- November 26, 2010
- Report Date
- November 26, 2010
- Manufacturer
- BAXTER HEALTHCARE - SWINFORD
- Product Code
- FKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE EVALUATION EXPECTED, BUT NOT YET COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.
Additional Manufacturer Narrative · 1
(B)(4). THIS COMPLAINT FOR A CRACKED MINICAP WAS CONFIRMED; HOWEVER, THE ASSIGNABLE CAUSE WAS NOT DETERMINED. A BATCH REVIEW WAS PERFORMED, AND NO ISSUES WERE NOTED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS.
Description of Event or Problem · 1
A BAXTER SALES REPRESENTATIVE REPORTED A CRACK WAS FOUND ON THE CAP DURING USE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MINICAP PREP KIT JAPAN | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - SWINFORD | 10E27H17 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |