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
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.
Event or Problem Description
According to the complainant, during disinfection, particles were observed in the infusion line of the pump.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number: (b)(4).Multiple photos were submitted to the manufacturer for evaluation.Two photos were provided showing an easypump ii sample that was filled with clear solution, observed with a particle on its outer shell.These photos were enlarged to fit the size of an actual pump for measuring the particle; the estimate particle size was 0.6 mm².According to test specification in the non-fluid path, no contaminant with a size greater than 0.8 mm² is allowed.Therefore, the sample within the photo is still within specification.Five photos were provided showing easypump ii samples filled with a clear solution, observed with a nylon film at the o-ring of these pumps.The end of the nylon film will thicken and form a thick white layer upon assembly due to the heat applied during the nylon wrapping process.This is a normal condition of nylon film after production.As no sample was received, further investigation is not possible for this issue.One photo was provided showing an easypump ii sample that was filled with a clear solution, observed with a dark particle on its tube.The tube was attached onto the outer shell of the sample by a white tape.The photo was enlarged to fit the size of an actual pump for measuring the particle; the estimated particle size is 0.4 mm².According to test specification, only one contaminant smaller or equal to 0.5 mm² is allowed.Therefore, the contaminant is still within specification.A review of the device history record (dhr) was performed for the reported lot number and no abnormalities or non-conformance's were noted during the in process or final product inspection.Based on the investigation of the photos, the samples within are still within specification and the complaint is considered not confirmed.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: jonathan severino ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 23366286
• Report Number: 9610825-2025-00617
• Device Sequence Number: 9931929
• 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): 11/20/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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