MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. BRAUN EASYPUMP 250 175ML/HR; PUMP, INFUSION, ELASTOMERIC

Catalog Number 08021-0010-34

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2023

Event Type  malfunction  

Event Description

Leaking easy pump from base of mediball.Found prior to leaving pharmacy.

• Brand Name: BRAUN EASYPUMP 250 175ML/HR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 16436557
• MDR Text Key: 310330985
• Report Number: MW5115142
• 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: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 08021-0010-34
• Device Lot Number: 22B17GE72R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MEDIBALL.
• Patient Age: 50 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 45 KG