FDA Adverse Event
Injury
Summary report: N
31G X 5MM BD PEN NEEDLE
MDR report key: 2033904
·
Received March 18, 2011
Report
- Report Number
- 9616656-2011-00012
- Event Type
- Injury
- Date Received
- March 18, 2011
- Date of Event
- February 4, 2011
- Report Date
- March 17, 2011
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMI
- PMA / PMN Number
- K051899
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT HAS BEEN RECEIVED TO DATE, IF PRODUCT IS RETURNED, ANALYSIS WILL BE CONDUCTED. COMPLAINT HISTORY CHECK YIELDED NO OTHER COMPLAINTS FOR SIMILAR CONDITION FOR THE LOT REPORTED. NO OBVIOUS TRENDS WERE NOTED. DEVICE HISTORY REVIEW WAS CONDUCTED AND NO ANOMALIES NOTED. REGULATORY COMPLIANCE WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.
Description of Event or Problem · 1
COMPANY REP STATED NEEDLE STAYED UNDER CONSUMER'S SKIN AND HAD TO BE REMOVED SURGICALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 31G X 5MM BD PEN NEEDLE | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | BECTON DICKINSON | NA | 0125159 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |