MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD CATHENA¿ SAFETY IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	386860
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Multiple 24g pivs [peripheral intravenous lines] leaking during appointments in outpatient infusion at site where piv connects to catheter extension set.Piv does not leak when checking blood return but when flushing, piv leaks.

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 24130209
• Report Number: 24130209
• Device Sequence Number: 10400168
• Product Code: FOZ
• UDI-Device Identifier: 00382903868605
• UDI-Public: (01)00382903868605
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/29/2025
• Report Date (Section F): 12/29/2025

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
• Device Model Number: 386860
• Device Catalogue Number: 386860
• Device Lot Number: 4311212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/21/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/21/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/29/2025