FDA Adverse Event
Injury
Summary report: N
BD AUTOSHIELD DUO PEN NEEDLE
MDR report key: 3802853
·
Received May 1, 2014
Report
- Report Number
- 2243072-2014-00093
- Event Type
- Injury
- Date Received
- May 1, 2014
- Date of Event
- February 24, 2013
- Report Date
- April 30, 2014
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMF
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. WITHOUT A SAMPLE, A ROOT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION REGARDING THE INCIDENT HAS BEEN REQUESTED. IF INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
THE CLINICIAN HAD GIVEN AN INSULIN SHOT TO AN (B)(6) PATIENT. THE NEEDLE THEN STUCK THE CLINICIAN AFTER THE SHOT WAS ADMINISTERED. AS A RESULT, THE CLINICIAN WAS REQUIRED TO UNDERGO MEDICAL TREATMENT, WHICH CAUSED HER WHITE BLOOD CELL COUNT TO DROP AND SHE BECAME ILL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 261133 | BD AUTOSHIELD DUO PEN NEEDLE | PEN NEEDLE | FMF | BECTON DICKINSON | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |