FDA Adverse Event
Malfunction
Summary report: N
EASYPUMP
MDR report key: 16363542
·
Received February 10, 2023
Report
- Report Number
- MW5114877
- Event Type
- Malfunction
- Date Received
- February 10, 2023
- Date of Event
- January 25, 2023
- Report Date
- February 8, 2023
- Manufacturer
- B. BRAUN MEDICAL INDUSTRIES SDN. BHD.
- Product Code
- MEB
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- UT, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
EASYPUMP 270/10 BEGAN LEAKING AS TECHNICIAN WAS COMPOUNDING. DISCARDED AND MADE A NEW ONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2235632 | EASYPUMP | PUMP, INFUSION, ELASTOMERIC | MEB | B. BRAUN MEDICAL INDUSTRIES SDN. BHD. | II LT 270-27-S |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |