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