MAUDE Adverse Event Report: B. BRAUN MEDICAL INDUSTRIES SDN. BHD. EASYPUMP; PUMP, INFUSION, ELASTOMERIC

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Easypump leaking after medication added.

• Brand Name: EASYPUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN MEDICAL INDUSTRIES SDN. BHD.
• MDR Report Key: 16372277
• MDR Text Key: 309593751
• Report Number: MW5114905
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2023
• Patient Sequence Number: 1
• Patient Age: 71 YR