FDA Adverse Event
Injury
Summary report: N
VENFLON PRO SAFETY 20G 1.1MM
MDR report key: 3010966
·
Received March 15, 2013
Report
- Report Number
- 2243072-2013-00012
- Event Type
- Injury
- Date Received
- March 15, 2013
- Date of Event
- January 30, 2013
- Report Date
- March 15, 2013
- Manufacturer
- BECTON DICKINSON
- Product Code
- BSO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A SAMPLE HAS NOT BEEN RECEIVED AND A ROOT CAUSE HAS NOT BEEN DETERMINED. IF A SAMPLE ARRIVES FOR INVESTIGATION A SUPPLEMENTAL WILL BE COMPLETED AND POTENTIAL ROOT CAUSE WILL BE DETERMINED.
Description of Event or Problem · 1
ON (B)(6) 2013, THE CUSTOMER WAS OPENING A PACKAGED DEVICE WHEN THE DEVICE SPRANG OUT OF THE PACKAGE AND THE NEEDLE PART OF THE DEVICE PENETRATED AND INJURED THEIR RIGHT EYE. ON AN UNK DATE, SURGERY WAS PERFORMED ON THE EYE TO CLEAN OUT THE BLOOD CLOT AND SUTURE THE REPAIR OF THE RETINA OF THE INJURED EYE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 110462 | VENFLON PRO SAFETY 20G 1.1MM | CATHETER | BSO | BECTON DICKINSON | 2116422P02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |