FDA Adverse Event
Injury
Summary report: N
BD ECLIPSE¿ NEEDLE
MDR report key: 7096018
·
Received December 7, 2017
Report
- Report Number
- 8041187-2017-00255
- Event Type
- Injury
- Date Received
- December 7, 2017
- Date of Event
- September 21, 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 AN BD ECLIPSE¿ NEEDLE THE SAFETY CAP WAS DEFECTIVE AND WOULDN'T CLOSE. THE NEEDLE BENT UP AND STUCK HER ON THE INDEX FINGER. 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 |
|---|---|---|---|---|---|---|---|
| 874204 | BD ECLIPSE¿ NEEDLE | SAFETY ENGINEERED HYPODERMIC NEEDLE | FMI | BECTON DICKINSON MEDICAL (SINGAPORE) | UNKNOWN | 30382903057666 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |