FDA Adverse Event
Malfunction
Summary report: N
FLOPUMP
MDR report key: 6322604
·
Received February 10, 2017
Report
- Report Number
- 1645362-2017-00001
- Event Type
- Malfunction
- Date Received
- February 10, 2017
- Date of Event
- May 25, 2016
- Report Date
- February 9, 2017
- Manufacturer
- INTERNATIONAL BIOPHYSICS CORPORATION
- Product Code
- KFM
- UDI-DI
- 00814321020094
- PMA / PMN Number
- K983272
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT WAS RETURNED AND EVALUATED, IT WAS DETERMINED THAT THE PRODUCT HAD A CRACK IN THE BASE ALONG THE SHAFT..
Description of Event or Problem · 1
PER CUSTOMER COMPLAINT REPORT, THE FLOPUMP CONTAINED CRACKS ON THE BASE OF THE PRODUCT. THE CRACK WAS NOTICED DURING PRIMING OF THE PUMP AND THE DEVICE WAS NOT USED WITH THE PATIENT AT ALL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 105459 | FLOPUMP | FLOPUMP | KFM | INTERNATIONAL BIOPHYSICS CORPORATION | 103015-3833 | 00814321020094 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |