FDA Adverse Event
Injury
Summary report: N
BD ECLIPSE¿ NEEDLE
MDR report key: 7099779
·
Received December 8, 2017
Report
- Report Number
- 8041187-2017-00257
- Event Type
- Injury
- Date Received
- December 8, 2017
- Date of Event
- October 27, 2017
- Report Date
- November 29, 2017
- Manufacturer
- BECTON DICKINSON MEDICAL (SINGAPORE)
- Product Code
- FMI
- UDI-DI
- 30382903057666
- PMA / PMN Number
- K161170
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. CAPAS (B)(4) WERE OPENED TO IDENTIFY AND ADDRESS THE POTENTIAL CAUSES OF SAFETY SHIELD DISENGAGEMENT. ADDITIONALLY, FIELD ACTION NOTIFICATION MSS-16-837-FA WAS INITIATED AND A PRODUCT ADVISORY LETTER WAS SENT ON 12/29/2016.
Description of Event or Problem · 1
WHEN USING A BD ECLIPSE¿ NEEDLE IT WAS REPORTED THAT THE CONSUMER WAS NEEDLE STICK TO THE RIGHT MIDDLE FINGER OCCURRED DURING DISPOSAL. THE SAFETY CAP CAME LOOSE AS SHE WAS DISPOSING INTO A SHARPS CONTAINER. MEDICAL INTERVENTION WAS REPORTED AS ¿FIRST AID AND SERIAL LABS FOR BLOOD BORNE INFECTIONS.¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 878110 | BD ECLIPSE¿ NEEDLE | SAFETY ENGINEERED HYPODERMIC NEEDLE | FMI | BECTON DICKINSON MEDICAL (SINGAPORE) | UNKNOWN | 30382903057666 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |