FDA Adverse Event
Death
Summary report: N
NIKO-FIX
MDR report key: 4337255
·
Received December 8, 2014
Report
- Report Number
- 3007966929-2014-00114
- Event Type
- Death
- Date Received
- December 8, 2014
- Date of Event
- November 1, 2014
- Report Date
- November 12, 2014
- Manufacturer
- UNOMEDICAL LTD.
- Product Code
- KMK
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A DEATH. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE.
Description of Event or Problem · 1
A HEALTH CARE PROFESSIONAL REPORTED AN UNSTERILE NIKO-FIX SECUREMENT WAS USED ON A PATIENT IN THE ONCOLOGY/HEMATOLOGY WARD. SOMETIME AFTER , THE PATIENT DEVELOPED SEPSIS AND EVENTUALLY EXPIRED. NO FURTHER INFORMATION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 789136 | NIKO-FIX | DEVICE, INTRAVASCULAR CATHETER SECUR | KMK | UNOMEDICAL LTD. | 417118 | 159428 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |