MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG EASYPUMP; PUMP, INFUSION, ELASTOMERIC

Catalog Number	4540040-02
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: 1 x foreign particle floating inside the membrane (fluid path) - (12112025@4) - post filling.1 x foreign particle floating inside the tubing (fluid path) - (12112025@4) - post filling.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow-up will be submitted when the investigation results become available.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Foreign matter fluid path.Through visual examination of one (1) sample, one loose contaminant was observed within the solution in the elastomeric membrane.The approximate size of the loose contaminant was 0.06 mm².According to test specification of elastomeric infusion systems for assembly, in the fluid path, one contaminant less than or equal to 0.5 mm² is allowed.The sample is within specification; the reported issue is not confirmed.Foreign matter - tube.Through visual examination of one (1) sample, a small black spot particle was observed at the inner surface of the triangle tube.The approximate size of the particle is 0.15 mm².The small black spot particle was observed embedded at the inner surface of the triangle tube.It was determined that this particle originated from material build up at the tip of the inner pin hole.This build up is typical of the extrusion process, where residual material can accumulate over time and eventually detach, a phenomenon commonly associated with die drool.Based on the investigation, the sample is still within specification.However, because the defect is still visually noticeable, the reported issue is considered confirmed.Corrective actions include retraining to ensure technicians correctly follow sop extrusion of tubing to avoid material buildup we will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: EASYPUMP
• Common Device Name: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: elena reifenstein ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 24317480
• Report Number: 9610825-2026-00078
• Device Sequence Number: 12174946
• Product Code: MEB
• UDI-Device Identifier: 04046964448942
• UDI-Public: (01)04046964448942(11)241215(17)291201(10)24N15GE671
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K081905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 4540040-02
• Device Lot Number: 24N15GE671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown