MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. BBRAUN EASYPUMP; PUMP, INFUSION, ELASTOMERIC

Device Problems Leak/Splash (1354); Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 07/15/2022

Event Type  malfunction  

Event Description

Braun elastomeric ball leaked most of fluid out into the bag.Cap was missing off of container.

• Brand Name: BBRAUN EASYPUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.
• MDR Report Key: 16335100
• MDR Text Key: 309270363
• Report Number: MW5114790
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/03/2023

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 Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic