FDA Adverse Event
Other
Summary report: N
BD AUTOSHIELD PEN NEEDLE
MDR report key: 1408894
·
Received March 20, 2009
Report
- Report Number
- 9610847-2008-00090
- Event Type
- Other
- Date Received
- March 20, 2009
- Date of Event
- October 21, 2008
- Report Date
- March 20, 2009
- Manufacturer
- BD MEDICAL - INFUSION THERAPY SYSTEMS
- Product Code
- FMI
- PMA / PMN Number
- K060007
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT HAS BEEN DISCARDED; NO PRODUCT RETURN IS ANTICIPATED. COMPLAINT HISTORY REVIEW CONDUCTED ON LOT NUMBER REPORTED (8150878) YIELDED NO OTHER COMPLAINTS RECORDED AGAINST THE LOT. WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.
Description of Event or Problem · 1
NURSE REPORTS THE WHITE PLASTIC COVER BROKE OFF, WHEN REMOVING USED NEEDLE FROM INSULIN PEN AFTER INJECTION. NURSE WAS STUCK WITH EXPOSED NEEDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD AUTOSHIELD PEN NEEDLE | 29 GA X 12.7MM PEN NEEDLE | FMI | BD MEDICAL - INFUSION THERAPY SYSTEMS | NA | 8150878 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |