FDA Adverse Event
Injury
Summary report: N
PEN NEEDLE
MDR report key: 3072391
·
Received April 19, 2013
Report
- Report Number
- 2243072-2013-00035
- Event Type
- Injury
- Date Received
- April 19, 2013
- Date of Event
- January 1, 2013
- Report Date
- April 19, 2013
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT HAS BEEN RECEIVED TO DATE, IF PRODUCT IS RETURNED, ANALYSIS WILL BE CONDUCTED.
Description of Event or Problem · 1
THE REPORTER STATED THAT THE NEEDLE BROKE OFF DURING INJECTION IN THE ABDOMEN. THE PATIENT WENT TO THE HOSPITAL, SURGICAL TREATMENT WAS NECESSARY. THE NEEDLE COULD NOT BE FOUND IN THE ABDOMEN. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 169939 | PEN NEEDLE | 31G X 8 | FMI | BECTON DICKINSON | 2247232 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |