FDA Adverse Event
Other
Summary report: N
BD UF 30 G 1/2 CC SYRINGE
MDR report key: 1780904
·
Received July 26, 2010
Report
- Report Number
- 1920898-2010-00010
- Event Type
- Other
- Date Received
- July 26, 2010
- Date of Event
- July 1, 2010
- Report Date
- July 26, 2010
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMF
- PMA / PMN Number
- K024112
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- 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 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, THE NEEDLES HAVE BURRS AND CAUSES HER TO HAVE SCARS AND BRUISING. NO MEDICAL ATTENTION WAS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD UF 30 G 1/2 CC SYRINGE | INSULIN SYRINGE | FMF | BECTON DICKINSON | NA | 0013938 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Disability |