FDA Adverse Event
Injury
Summary report: N
BD ECLIPSE NEEDLE 22G X 1"
MDR report key: 4795840
·
Received May 20, 2015
Report
- Report Number
- 2243072-2015-00096
- Event Type
- Injury
- Date Received
- May 20, 2015
- Report Date
- May 20, 2015
- Manufacturer
- BD
- Product Code
- FMI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A SAMPLE IS AVAILABLE FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MFG OF THE REPORTED LOT NUMBER 4202300. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE USING A BD ECLIPSE NEEDLE OR A PT INJECTION, THE CLINICIAN OBTAINED A NEEDLE STICK INJURY. THE CLINICIAN STATED THAT A PORTION OF THE NEEDLE REMAINED EXPOSED AFTER FULLY ACTIVATING THE SAFETY MECHANISM. THE CLINICIAN WAS EVALUATED IN THE ER AND ROUTINE POST EXPOSURE LAB WORK WAS DONE FOR BOTH THE CLINICIAN AND SOURCE PT. THE CLINICIAN ALSO REC'D ANTIRETROVIRAL MEDICATION POST EXPOSURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 329325 | BD ECLIPSE NEEDLE 22G X 1" | HEPODERMIC NEEDLE | FMI | BD | 4202300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |