FDA Adverse Event
Injury
Summary report: N
31G X 8MM PEN NEEDLE
MDR report key: 2389848
·
Received December 21, 2011
Report
- Report Number
- 9616656-2011-00038
- Event Type
- Injury
- Date Received
- December 21, 2011
- Date of Event
- November 21, 2011
- Report Date
- December 21, 2011
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMI
- PMA / PMN Number
- K051899
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT RETURN IS ANTICIPATED AS COMPLAINT INDICATES THAT THE PRODUCT HAS BEEN DISCARDED. COMPLAINT HISTORY CHECK YIELDED ONE OTHER COMPLAINT 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
SPECIALTY HEALTH NETWORK REPRESENTATIVE REPORTED 31G PEN NEEDLE BROKE IN CUSTOMER'S SKIN DURING INJECTION. APPOINTMENT WAS MADE TO HAVE THE NEEDLE REMOVED, BUT NOT SURE IF THE PATIENT WENT TO HAVE IT REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 31G X 8MM PEN NEEDLE | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | BECTON DICKINSON | NA | 1104796 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |