MAUDE Adverse Event Report: B. Braun Melsungen AG EASYPUMP; PUMP, INFUSION, ELASTOMERIC

Catalog Number	4540018-02
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The clamp clip was unclamped and white external stopper was removed from the sample; no solution flow was observed.Crystallization was observed inside the filter and microbore tube connection.The sample was filled with red dye solution and no damage or leakage was observed at the valve and filling port, silicone sleeve and no leakage was observed between the step down tube and triangle tube.The sample was further investigated to determine any leakage point.No leakages at the connection between triangle tube and filter nor between the microbore tube and patient connector were observed.A review of the batch manufacturing record (bmr) was performed for the reported lot number, and no abnormalities or non-conformances were noted during the in process or final product inspection.Based on the investigation, the reported issue of leakage could not be observed or replicated.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: elena reifenstein ; 824 12th ave; bethlehem, PA 18018 ; +1(833)425-1464
• MDR Report Key: 50321718
• Report Number: 9610825-2026-00434
• Device Sequence Number: 15923502
• Product Code: MEB
• UDI-Device Identifier: 04046964448638
• UDI-Public: (01)04046964448638(11)250903(17)300901(10)25K03GE561
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K081905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026

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: 4540018-02
• Device Lot Number: 25K03GE561
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/19/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2025
• 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