FDA Adverse Event
Injury
Summary report: N
VACUTAINER ++SF-L 25G 3/4
MDR report key: 11163483
·
Received January 12, 2021
Report
- Report Number
- MW5098802
- Event Type
- Injury
- Date Received
- January 12, 2021
- Report Date
- January 9, 2021
- Manufacturer
- BECTON DICKINSON AND COMPANY
- Product Code
- FMI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
PATIENT IS REQUESTING A DIFFERENT NEEDLE FOR HER INFUSIONS. THE ONES THAT WE HAVE SENT HAVE CAUSED HER VEINS TO BLOW. SHE HAS HAD 2 OUT OF 3 INFUSION ENDS WITH AT LEAST ONE VEIN BLOWN. NO OTHER INFORMATION PROVIDED. CONSENT TO CONTACT THE PATIENT'S ¿HEP¿ WAS NOT ASKED ALL KNOWN INFORMATION IS CONTAINED ON THIS FORM. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 54267 | VACUTAINER ++SF-L 25G 3/4 | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | BECTON DICKINSON AND COMPANY | BE367298 | ||
| 54268 | VACUTAINER ++SF-L 25G 3/4 | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | BECTON DICKINSON AND COMPANY | BE367298 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |