FDA Adverse Event
Malfunction
Summary report: N
MINICAP
MDR report key: 4546556
·
Received February 25, 2015
Report
- Report Number
- 1416980-2015-07355
- Event Type
- Malfunction
- Date Received
- February 25, 2015
- Report Date
- January 29, 2015
- Manufacturer
- BAXTER HEALTHCARE - CLEVELAND
- Product Code
- KDI
- PMA / PMN Number
- K895631
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). THIS LOT WAS MANUFACTURED FROM 11/4/2014 ¿ 11/18/2014. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). THIS LOT WAS MANUFACTURED FROM 11/4/2014 ¿ 11/11/2014.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS NO VISIBLE IODINE IN THE SPONGE OF A MINICAP. THIS WAS NOTED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 132480 | MINICAP | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | BAXTER HEALTHCARE - CLEVELAND | GD898080 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |