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	Chemical Exposure (2570)
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, a patient received fluorouracil through a 270 milliliter (ml) easypump and the medication leaked out of the tubing onto his bare chest.No irritation of the skin or patient complications were reported as a result of the event.The patient is doing fine.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Four (4) photos were submitted to the manufacturer for evaluation.Through visual examination of the photos, the 5 ml/h filter of the easypump ii was observed with some white precipitation around the filter area.However, from the images provided, the investigation team was unable to further assess the reported leakage defect.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.The sample package was shown to have been picked up by ups from the customer facility.However, after a claim was filed, ups noted that the package has been lost and has not been delivered to the investigation site for a thorough investigation.Based on the data from the investigation we are unable to determine the root cause of the reported incident.The reported defect was unable to be confirmed.In the event the sample package is found and delivered, we will reopen the investigation for technical analysis.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: 24257513
• Report Number: 9610825-2026-00015
• Device Sequence Number: 8327194
• Product Code: MEB
• UDI-Device Identifier: 04046964448638
• UDI-Public: (01)04046964448638(17)300201(10)25B01GE561
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/17/2026

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: 4540018-02
• Device Lot Number: 25B01GE561
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2025
• 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: Male