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)
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: event 3: we've had several instances over the last week of chemo pumps patients wear to take home leaking due to faulty bungs.We are quite sure of the cause, as the bung isn't leaking when the patient is on the unit with us, but happening when they go home with the pump attached for a 48 hour period.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 photograph, the item number was observed on the package along with the lot number and expiration date.No definitive conclusions were able to be made.It was determined the photograph did not provide sufficient evidence of the reported concern.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.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 21297647
• Report Number: 2523676-2025-00054
• Device Sequence Number: 21131894
• Product Code: FPA
• UDI-Device Identifier: 04046964115998
• UDI-Public: (01)04046964115998(11)240903(17)270831(10)0061956679
• 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): 03/25/2025

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: 0061956679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2024
• 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