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

Catalog Number	4540016-02
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
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: brief inquiry description: leaking during 5fu infusion with easypump.Detailed inquiry description: "we had a patient that experienced a leak with his 5fu pump.I s/w the patient yesterday evening and they indicated there was a white residue all over their black bag and that it was damp.I instructed them to put it into the chemotherapy bag and close the bag to the tubing and let it continue to run positioning to ensure no drug could leak from the bag--if they noticed drug pooling in the bag-clamp it and come in first thing.I s/w the patient at 8am and they said there was just drops in the bag." no injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample or photos were submitted to the manufacturer for evaluation.A review of the non-conformance system database was performed for the reported lot number and no abnormalities or nonconformances were noted during the in process or final product inspection.The reported defect could not be 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, ELASTOMERI
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 19217406
• Report Number: 9610825-2024-00332
• Device Sequence Number: 7016768
• Product Code: MEB
• UDI-Device Identifier: 04046964448607
• UDI-Public: (01)04046964448607
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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: 23E19GE551
• 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: 04/24/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2023
• 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