MAUDE Adverse Event Report: B BRAUN MEDICAL INC EASYPUMP 2; ELASTOMERIC PUMPS

Model Number 4540016-07

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/05/2024

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).A follow-up report will be provided after the examination results are available.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.

Event Description

As reported by the user facility information by bbm sales organization in france: "product-leakage-tube container" according to the customer: "patient came in today because his diffuser had been leaking since yesterday evening.Says he saw the leak in the tubing at the balloon outlet.".

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.Root cause analysis: received 1 sample without original packaging.The batch number on the bbc (big bottom cap) of the complaint sample is (b)(6).The complaint sample was filled with solution and bbc was removed.Leakage was observed at triangle tube to step down tube connection.Summary of root cause analysis: the complaint sample was leaking at triangle tube to step down tube connection.Thus, we considered this complaint as confirmed.An approved project has been raised to address triangle tube to step down tube connection leakage issue.Cause: failure in production process corrections/containment plans with effective date: not applicable.

• Brand Name: EASYPUMP 2
• Type of Device: ELASTOMERIC PUMPS
• Manufacturer (Section D): B BRAUN MEDICAL INC; 901 marcon blvd.; allentown PA 18109
• Manufacturer (Section G): B BRAUN MEDICAL INC; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18841717
• MDR Text Key: 336976902
• Report Number: 9610825-2024-00153
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2024

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: Health Professional
• Device Model Number: 4540016-07
• Device Lot Number: 22L01GED8R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male