FDA Adverse Event
Injury
Summary report: N
31G X 8MM PEN NEEDLE
MDR report key: 1974322
·
Received January 21, 2011
Report
- Report Number
- 9616656-2011-00005
- Event Type
- Injury
- Date Received
- January 21, 2011
- Date of Event
- December 27, 2010
- Report Date
- January 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 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
CONSUMER REPORTED AFTER SHE DID HER INJECTION ON (B)(6), 2010, SHE NOTICED THAT THE NEEDLE NOT THERE WHEN REMOVED IT. BROKEN NEEDLE WAS LOCATED ON X-RAY AND SURGERY WAS SCHEDULED ON (B)(6), 2011 TO HAVE NEEDLE 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 | 0033371 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |