FDA Adverse Event
Malfunction
Summary report: N
SYRINGE 1ML L/L NO NEEDL BD
MDR report key: 23647498
·
Received November 25, 2025
Report
- Report Number
- MW5179423
- Event Type
- Malfunction
- Date Received
- November 25, 2025
- Report Date
- November 21, 2025
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- US
- Reporter Occupation
- 003
- Health Professional
- N
Narratives
Description of Event or Problem · 0
PATIENT REPORTED THAT HE MISSED HIS DOSE OF CORTROPHIN BECAUSE HIS SYRINGE WITH NEEDLE BROKE AND HE DID NOT HAVE EXTRAS. PATIENT ASKED FOR EXTRA SUPPLIES WITH NEXT ORDER. REPLACEMENT NEEDLES AND SYRINGES SENT TO PATIENT. NO ADVERSE EVENTS REPORTED. UNKNOWN IF AVAILABLE FOR RETURN. NO FURTHER INFORMATION PROVIDED. FREQUENCY: 2 CONSECUTIVE DAYS A MONTH. MULTIPLE SCLEROSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1948105 | SYRINGE 1ML L/L NO NEEDL BD | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | BECTON DICKINSON |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | CORTROPHIN GEL MDV. |