FDA Adverse Event
Injury
Summary report: N
BD INSULIN SYRINGE
MDR report key: 2922154
·
Received January 11, 2013
Report
- Report Number
- 1920898-2013-00001
- Event Type
- Injury
- Date Received
- January 11, 2013
- Date of Event
- December 13, 2012
- Report Date
- January 11, 2013
- Manufacturer
- BD
- Product Code
- FMF
- PMA / PMN Number
- K024112
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT HAS BEEN RECEIVED TO DATE. COMPLAINT HISTORY CHECK YIELDED NO OTHER COMPLAINTS FOR SIMILAR CONDITIONS FOR THE LOT REPORTED. DEVICE HISTORY REVIEW WAS CONDUCTED AND NO ANOMALIES NOTED. QUALITY WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.
Description of Event or Problem · 1
CUSTOMER HAD A NEEDLE BREAK OFF IN ABDOMEN. SHE WENT TO THE EMERGENCY ROOM AND HAD AN X-RAY. DOCTOR WAS NOT ABLE TO PULL THE NEEDLE OUT. CUSTOMER HAD ANOTHER SURGERY ON (B)(6) 2012 FOR REMOVAL OF BROKEN NEEDLE FRAGMENT. THE NEEDLE WAS NOT FOUND IN THE REMOVED TISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 17130 | BD INSULIN SYRINGE | 1/2ML X 31G X 8MM INSULIN SYRINGE | FMF | BD | 9292943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |