MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. CARESITE®; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	415122-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
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: clearly demonstrated that the 5-fu leak was from the bung on the pump.No contact was made with his skin, he was asymptomatic and had normal observations.The port was healthy with no evidence of a reaction.Clinical update: was there any patient/user harm because of the incident? if so, please provide further clinical information such as patient outcome and any additional therapy required as a result.No contact was made with his skin, he was asymptomatic and had normal observations.The port was healthy with no evidence of a reaction.Which procedure was being carried out at the time? continuous 48 hour infusion via pump.Was there any delay to the procedure because of this incident? if so, please quantify as accurately as possible.Yes, patient treatment was stopped until able to attend the following day.Delay approx.12 hours.Is there a sample available to collect? yes, sample was kept in aseptic's unit.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).A review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.No sample was provided for evaluation.Based on the data from the investigation, the root cause of the reported incident was unable to be determined.The reported defect was unable to be confirmed.The exact root cause was unable to be determined at this time.However, incidents of cracked/leaking valves may be caused by several factors, including but not limited to the product being subjected to aggressive solvents/drugs, excessive mechanical stresses (over-tightening or frequent set manipulation), or other various unforeseen circumstances during the clinical application.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: CARESITE®
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 21432258
• Report Number: 2523676-2025-00127
• Device Sequence Number: 4618190
• Product Code: FPA
• UDI-Device Identifier: 04046964115998
• UDI-Public: (01)04046964115998(11)240805(17)270731(10)0061951405
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140311
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

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: 415122-01
• Device Lot Number: 0061951405
• 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: 01/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2024
• 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