FDA Adverse Event
Malfunction
Summary report: N
MINICAP
MDR report key: 2852055
·
Received November 30, 2012
Report
- Report Number
- 1416980-2012-06228
- Event Type
- Malfunction
- Date Received
- November 30, 2012
- Date of Event
- October 18, 2012
- Report Date
- November 8, 2012
- Manufacturer
- BAXTER HEALTHCARE - GUANGZHOU
- Product Code
- KDI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. THIS COMPLAINT FOR A MISASSEMBLED MINICAP WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE SAMPLE WAS NOT RETURNED TO BAXTER, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED.
Description of Event or Problem · 1
A DISTRIBUTOR CONTACTED BAXTER (B)(4) REGARDING A MISASSEMBLED MINICAP. THE DISTRIBUTOR STATED THE MINI CAP SPONGE CAME OUT FROM THE MINI CAP. THERE WAS NO PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED ALONG WITH THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MINICAP | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | BAXTER HEALTHCARE - GUANGZHOU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |