MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. PORT ACCESS NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	0632234
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient said, "i am leaking" upon investigation the bd miniloc safety infusion set was leaking at the connection site to infusion.Stopped the infusion.Tried flushing.This did not solve the problem, removed the needle, re-accessed patient with new needle and cap.This solved the leak.On-going issue with this device.

• Brand Name: PORT ACCESS NEEDLE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 24638095
• Report Number: 24638095
• Device Sequence Number: 18693897
• Product Code: FPA
• UDI-Device Identifier: 00801741047602
• UDI-Public: (01)00801741047602
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2026
• Report Date (Section F): 02/27/2026

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 Model Number: 0632234
• Device Catalogue Number: 0632234
• Device Lot Number: ASKFC043
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/27/2026