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

Catalog Number	415122
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
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: complaint: while administering anti-cancer drugs, the medical solution leaked from somewhere.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) sample was submitted to the manufacturer for evaluation.Through visual examination, a crack on the threads of the caresite body was observed.The sample was then tested per specification with failing results; leakage was observed coming from the crack on the threads of the caresite body.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.Although a defect was observed, the defect is not considered to be related to any manufacturing process.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, INTRA
• 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: 18271172
• Report Number: 2523676-2023-00786
• Device Sequence Number: 3894134
• Product Code: FPA
• UDI-Device Identifier: 04046964115998
• UDI-Public: (01)04046964115998
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/01/2024

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 Expiration Date: 01/31/2026
• Device Catalogue Number: 415122
• Device Lot Number: 0061870596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2023
• 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