FDA Adverse Event
Malfunction
Summary report: N
MINICAP
MDR report key: 3945154
·
Received July 18, 2014
Report
- Report Number
- 1416980-2014-23396
- Event Type
- Malfunction
- Date Received
- July 18, 2014
- Report Date
- June 25, 2014
- Manufacturer
- BAXTER HEALTHCARE - CUERNAVACA
- Product Code
- KDI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. AS THE SAMPLE WAS NOT RETURNED, A COMPLETE DEVICE EVALUATION CANNOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PACKAGING FOR A MINICAP WAS OPEN. THIS WAS OBSERVED BEFORE USE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 13 OF 13.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 423272 | MINICAP | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | BAXTER HEALTHCARE - CUERNAVACA | M14B18A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |