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	10/10/2025
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: during therapy the device returned blood.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One photograph was provided for investigation.Upon evaluation of the image, the presence of blood was observed inside the caresite.The reported issue was not confirmed.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.Retains were tested per specification and passed.The most probable root cause was determined to be the result of coagulation of blood or other residue around the valve disk during product use, preventing valve closure.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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Three (3) samples and one (1) photograph were submitted to the manufacturer for evaluation.Through visual examination of the photo, the presence of blood was observed inside the caresite.The reported issue of leakage was unable to be observed within the photo.Through visual examination of the received used samples, it was observed that the samples contained blood residue.The samples were decontaminated; however, traces of blood remained in the samples.The samples were then leak tested per specification and all of the samples passed with no deviations observed.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.Retained samples were examined and the samples were within specification.Based on the investigation, the reported issue could not be observed or replicated.The samples were 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: 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: 23476646
• Report Number: 2521402-2025-01347
• Device Sequence Number: 16075895
• 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: 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2026

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: 415122
• Device Lot Number: 0061978567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 11/24/2025; 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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