FDA Adverse Event
Injury
Summary report: N
EASYPUMP ST 250ML-175ML/HR
MDR report key: 16789732
·
Received April 20, 2023
Report
- Report Number
- MW5116894
- Event Type
- Injury
- Date Received
- April 20, 2023
- Date of Event
- January 26, 2023
- Report Date
- April 17, 2023
- Manufacturer
- B. BRAUN MEDICAL INDUSTRIES SDN. BHD.
- Product Code
- MEB
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MN, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
ELASTOMERIC PUMP USED FOR ANTIBIOTIC THERAPY LEAKED - DOSE WAS DELAYED/MISSED AS PHARMACY HAD TO REMAKE DOSE AND SHIP TO PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1521805 | EASYPUMP ST 250ML-175ML/HR | PUMP, INFUSION, ELASTOMERIC | MEB | B. BRAUN MEDICAL INDUSTRIES SDN. BHD. | 4540050 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Male | Required Intervention | VANCOMYCIN IN NS-01/06/2023-01/25/2023| VANCOMYCIN IN NS-01/27/2023-02/15/2023 |