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

Catalog Number	4540016-02
Medical Device Problem Code	Leak/Splash (1354)
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
As reported by the user facility: reason of complaint: we recently discharged a patient with a 5-fluorouracil infusion bulb, who returned today due to leakage.Upon inspection, it appears the leak originated at the seal between the cap and the bulb itself.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Five (5) samples were submitted to the manufacturer for evaluation.The discofix caps were removed; no crack lines were observed at the filling ports of all the reference samples.The samples were filled with red dye solution and left for 10 minutes.No leakage observed from the samples.A review of the device history record (dhr) 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 could not be observed or replicated.The samples are within specification.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 ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 24939975
• Report Number: 9610825-2026-00193
• Device Sequence Number: 5663483
• Product Code: MEB
• UDI-Device Identifier: 04046964448607
• UDI-Public: (01)04046964448607(11)240903(17)290901(10)24K03GE551
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): Unknown
• 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): 04/30/2026

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: 4540016-02
• Device Lot Number: 24K03GE551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2024
• 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