FDA Adverse Event
Malfunction
Summary report: N
MINICAP PD TRANSFER SET (EASY-LOCK) WITH TWIST CLAMP
MDR report key: 763972
·
Received August 3, 2006
Report
- Report Number
- 1423500-2006-00904
- Event Type
- Malfunction
- Date Received
- August 3, 2006
- Date of Event
- July 4, 2006
- Report Date
- July 6, 2006
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- KJJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: RESULTS INDICATE THAT THE LAB WAS NOT ABLE TO CONFIRM THE REPORTED EVENT. THERE ARE NO FURTHER MEASURES TAKEN RELATIVE TO THIS MATTER. RENAL PRODUCT SURVEILLANCE, QUALITY ENGINEERING, ALONG WITH PLANT MANUFACTURING, WILL CONTINUE TO MONITOR THIS PRODUCT LINE.
Description of Event or Problem · 1
BAXTER REPORTS THAT THE TWO COMPONENTS OF THE TWIST CLAMP WERE LIGHTLY BROKEN, AND THAT THE BREAK WAS ALMOST NOT DETECTABLE. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MINICAP PD TRANSFER SET (EASY-LOCK) WITH TWIST CLAMP | TRANSFER SET | KJJ | BAXTER HEALTHCARE CORPORATION | NA | NA01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR |