FDA Adverse Event
Injury
Summary report: N
BD NEXIVA CLOSED IV ACCESS SYSTEM
MDR report key: 2442533
·
Received February 1, 2012
Report
- Report Number
- 1710034-2012-00006
- Event Type
- Injury
- Date Received
- February 1, 2012
- Date of Event
- January 18, 2012
- Report Date
- February 1, 2012
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
- Product Code
- DQO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE IS AVAILABLE FOR EVAL. ADD'L INFO REGARDING THIS INCIDENT HAS BEEN REQUESTED. UPON RECEIPT OF THE SAMPLE AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
ONCE THE CATHETER WAS SUCCESSFULLY INSERTED, THE WHITE NEEDLE SEPTUM WAS FOUND LEAKING BLOOD AND AIR. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES AND NO HARM TO THE PT AS A RESULT OF THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD NEXIVA CLOSED IV ACCESS SYSTEM | INTRAVASCULAR CATHETER | DQO | BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. | NA | 1091114 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |