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

Lot Number 21M18GE671

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 02/08/2023

Event Type  malfunction  

Event Description

B.Braun easypump was found to have completely leaked all contents out of the side of the elastomeric.All clamps and caps were checked and verified for proper use/placement.

• Brand Name: B. BRAUN EASYPUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN MEDICAL INDUSTRIES SDN. BHD.
• MDR Report Key: 16364412
• MDR Text Key: 309511253
• Report Number: MW5114886
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 02/08/2023

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
• Device Lot Number: 21M18GE671
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1