FDA Adverse Event
Injury
Summary report: N
BD MICRO FINE PEN NEEDLE
MDR report key: 3687552
·
Received March 12, 2014
Report
- Report Number
- 2243072-2014-00048
- Event Type
- Injury
- Date Received
- March 12, 2014
- Report Date
- March 12, 2014
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT HAS BEEN REC'D TO DATE, IF PRODUCT IS RETURNED, ANALYSIS WILL BE CONDUCTED. UNABLE TO RUN COMPLAINT HISTORY CHECK OR DEVICE HISTORY REVIEW AS LOT NUMBER IS UNKNOWN. QUALITY WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.
Description of Event or Problem · 1
OB (B)(6) 2014, THE REPORTER STATED THAT THE NEEDLE BROKE OFF IN THE ABDOMEN AFTER INJECTION AND THE PATIENT VISITED THE HOSPITAL. ON AN UNKNOWN DATE, SURGICAL INTERVENTION WAS PERFORMED BUT THE NEEDLE WAS NOT FOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149096 | BD MICRO FINE PEN NEEDLE | INSULIN PEN NEEDLE | FMI | BECTON DICKINSON |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |