FDA Adverse Event
Malfunction
Summary report: N
MEDSTREAM
MDR report key: 22736662
·
Received August 7, 2025
Report
- Report Number
- 22736662
- Event Type
- Malfunction
- Date Received
- August 7, 2025
- Date of Event
- December 3, 2024
- Report Date
- June 26, 2025
- Manufacturer
- MEDICAL SPECIALTIES DISTRIBUTORS, INC.
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CT
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
THE 0.28ML, 0.2 MICRON DISC FILTER WAS UNABLE TO PROPERLY CONNECT TO IV TUBING, LEADING TO DELAYS IN CARE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 504735 | MEDSTREAM | SET, ADMINISTRATION, INTRAVASCULAR | FPA | MEDICAL SPECIALTIES DISTRIBUTORS, INC. | MSF475 | 14149982 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |