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

Catalog Number	415122
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
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: reason of complaint: blood return is seen, which should not happen, creating a risk of contamination for healthcare personnel.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Two photographs were provided for investigation.Upon evaluation of the images, the caresites appeared to be used with blood inside of the valve between the piston and the valve wall/ on the outside of the part.Blood was not observed underneath the valve on the patient wrap of the male connection of the valve.Based on this information, it was difficult to determine any potential leakage from the photographs provided.The reported issue was unable to be confirmed.All information concerning this reported incident has been included in our trend analysis of the product line.Based upon the photographs provided, it was not able to be determined if any defect was present on the used caresite valves.It appears there is some form of blood either within or on the valve, but no conclusions can be made without a physical sample.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.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.; 824 12th ave; bethlehem PA 18018
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 824 12th ave; bethlehem PA 18018
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 23328099
• Report Number: 2521402-2025-01203
• Device Sequence Number: 9845852
• Product Code: FPA
• UDI-Device Identifier: 04046964115998
• UDI-Public: (01)04046964115998(11)250127(17)271231(10)0061978567
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K083723
• 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): 11/23/2025

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
• Device Lot Number: 0061978567
• 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: 10/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 11/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2025
• 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