FDA Adverse Event
Injury
Summary report: N
BD INSULIN SYRINGE
MDR report key: 1031218
·
Received April 14, 2008
Report
- Report Number
- 1920898-2008-00006
- Event Type
- Injury
- Date Received
- April 14, 2008
- Date of Event
- March 19, 2008
- Report Date
- April 11, 2008
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMF
- PMA / PMN Number
- K024112
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT RETURN IS ANTICIPATED, AS COMPLAINANT INDICATES THAT THE PRODUCT HAS BEEN DISCARDED. UNABLE TO RUN COMPLAINT HISTORY CHECK OR DEVICE HISTORY REVIEW AS LOT NUMBER IS UNK. REGULATORY COMPLIANCE WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.
Description of Event or Problem · 1
CONSUMER REPORTED NEEDLE BROKE OFF ON INSULIN SYRINGE WHEN INJECTING. CONSUMER WAS REQUIRED TO VISIT ER FOR REMOVAL OF BROKEN CANNULA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD INSULIN SYRINGE | INSULIN SYRINGE | FMF | BECTON DICKINSON | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| R |