FDA Adverse Event
Other
Summary report: N
TEXIUM NEEDLE FREE SYRINGE D425905
MDR report key: 6144998
·
Received December 1, 2016
Report
- Report Number
- MW5066512
- Event Type
- Other
- Date Received
- December 1, 2016
- Report Date
- September 22, 2016
- Manufacturer
- BECTON DICKINSON AND CO.
- Product Code
- FMF
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
ON 2016, I HAD A BD TEXIUM SYRINGE THAT HAD A LEAK WITH 5FU IN IT. NO PATIENT WAS INVOLVED. THIS SYRINGE WAS NOT USED AND A NEW 5FU DOSE WAS DRAWN UP USING ANOTHER SYRINGE. I HAVE ATTACHED A PICTURE OF THE SYRINGE WITH THE LEAK. IT IS A TEXIUM 10 ML NEEDLE FREE SYRINGE. ITEM NUMBER: MY8010 LOT: D425905 EXP: 09-2017. THE LEAK OCCURRED WHILE PULLING THE 5FU INTO THE SYRINGE. THE PLUNGER ROD WAS NOT PULLED AT AN ANGLE TOWARD THE USER. VERTICAL ALIGNMENT WAS MAINTAINED. (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 790755 | TEXIUM NEEDLE FREE SYRINGE D425905 | TEXIUM NEEDLE FREE SYRINGE D425905 | FMF | BECTON DICKINSON AND CO. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |