FDA Adverse Event
Malfunction
Summary report: N
BD ECLIPSE NEEDLE 25 GAUGE 1"
MDR report key: 9290699
·
Received November 6, 2019
Report
- Report Number
- MW5090925
- Event Type
- Malfunction
- Date Received
- November 6, 2019
- Date of Event
- November 5, 2019
- Report Date
- November 5, 2019
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SA DE CV
- Product Code
- FMI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
MA ATTEMPTING TO CLOSE SAFETY DEVICE ON BD ECLIPSE 25G X 1 INCH INJECTION NEEDLE AND SAFETY DEVICE DETACHED FROM NEEDLE. NO INJURY TO PT OR EMPLOYEE. NEEDLE ATTACHED TO FLU VACCINE DISCARDED INTO SHARP BIN. LOT #8241495. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1078401 | BD ECLIPSE NEEDLE 25 GAUGE 1" | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SA DE CV | 113390, 8241495 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |