FDA Adverse Event
Malfunction
Summary report: N
MINI-CAP, DISCONNET WIPVP-1 SOLUTION
MDR report key: 2982283
·
Received June 4, 2007
Report
- Report Number
- 1423500-2007-00197
- Event Type
- Malfunction
- Date Received
- June 4, 2007
- Date of Event
- May 1, 2007
- Report Date
- May 7, 2007
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- KDI
- PMA / PMN Number
- K895631
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE WAS DISCARDED AND IS UNAVAILABLE FOR ANALYSIS. THERE ARE NO FURTHER MEASURES TO BE TAKEN RELATIVE TO THIS MATTER. RENAL PRODUCT SURVEILLANCE, QUALITY ENGINEERING, AND PLANT MFG WILL CONTINUE TO MONITOR THIS PRODUCT LINE AND TAKE CORRECTIVE/PREVENTATIVE ACTION AS APPROPRIATE.
Description of Event or Problem · 1
BAXTER (B)(6) REPORTED AN INCIDENT IN WHICH THE MINICAP FELL OFF THE TRANSFER SET BEFORE USE. NO PT INJURY OR MEDICAL INTERVENTION WAS ASSOCIATED WITH THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MINI-CAP, DISCONNET WIPVP-1 SOLUTION | DISCONNECT CAP | KDI | BAXTER HEALTHCARE CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |