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 400701066.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: issue delivering chemotherapy.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.Yes.Patient was connected to chemotherapy treatment which was to be infused over 48 hours.Chemotherapy treatment had leaked onto patient.Cytotoxic drug exposed to patient.Required assistance from 24 hour triage line and treatment was stopped until patient could attend the following day.Patient treatment delayed another 24 hours for full completion.Which procedure was being carried out at the time? delivery of 48 hour chemotherapy infusion.Was there any delay to the procedure because of this incident? if so, please quantify as accurately as possible.Yes.Patient treatment was delayed by additional 24 hours.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 patient/user harm.Leak was visibly noted by staff.Which procedure was being carried out at the time? antibiotic administration and portacath flush.Was there any delay to the procedure because of this incident? if so, please quantify as accurately as possible.Minor delay as had to find a suitable, working bung.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Two (2) used samples and six (6) photos were submitted to the manufacturer for evaluation.Through visual examination of the photos, it was observed that all six images depict a caresite valve connected to a syringe, with leakage occurring at the connection point between the valve and the syringe.Through visual examination of the returned samples, one sample was observed to have a vertical crack on the threads of the caresite body.This sample was subjected to leakage testing, which failed, as leakage was observed coming from the crack on the threads of the caresite body.The second sample was also tested for leakage and no leakages or abnormalities were observed.While an exact root cause could not be determined, review of the complaint samples and manufacturing records suggests that the defect did not originate from a failure in the manufacturing process.Based on these findings, the most likely potential cause of the defect is excessive force being placed on the valve during use.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.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: 21645568
• Report Number: 2523676-2025-00261
• Device Sequence Number: 7625197
• Product Code: FPA
• UDI-Device Identifier: 04046964115998
• UDI-Public: (01)04046964115998(11)241028(17)270930(10)0061966918
• 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): 04/21/2025

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: 0061966918
• 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: 02/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2024
• 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