FDA Adverse Event
Malfunction
Summary report: N
VASONOVA VASCULAR POSITIONING SYSTEM
MDR report key: 3904790
·
Received May 28, 2014
Report
- Report Number
- 3006795936-2014-00011
- Event Type
- Malfunction
- Date Received
- May 28, 2014
- Date of Event
- May 21, 2014
- Report Date
- May 22, 2014
- Manufacturer
- VASONOVA INC.
- Product Code
- OBJ
- PMA / PMN Number
- K083920
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
COMPLAINT NO. (B)(4).
Description of Event or Problem · 1
IT IS REPORTED THIS EVENT OCCURRED IN THE PATIENT'S ROOM. THE INSERTION SITE WAS THE UPPER ARM. FOLLOWING THE INSERTION OF A NAVILYST EXCELA PICC CATHETER, THE NURSE WAS UNABLE TO REMOVE THE BIOSENSOR FROM THE CATHETER. WHILE ATTEMPTING TO REMOVE THE BIOSENSOR, THE BIOSENSOR FRACTURED LEAVING A DISTAL PART OF IT IN THE CATHETER. THE NURSE STATED, HE REMOVED THE CATHETER AND REPLACED WITH A NEW CATHETER. NO DELAY IN TREATMENT WAS NOTED. THERE WAS NO REPORTED PATIENT INJURY, COMPLICATIONS, OR DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314867 | VASONOVA VASCULAR POSITIONING SYSTEM | CATHETER, ULTRASOUND, INTRAVASCULAR | OBJ | VASONOVA INC. | 19F14B0006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |