MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. PERIPHERAL CATHETER INSERTION KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	F318108PT
Health Effect - Clinical Code	Infiltration into Tissue (1931)
Date of Event	08/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Pt received a midline for home antibiotics and right before discharge, midline infiltrated.

• Brand Name: PERIPHERAL CATHETER INSERTION KIT
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 22792158
• Report Number: 22792158
• Device Sequence Number: 18214470
• Product Code: FOZ
• UDI-Device Identifier: 00801741140662
• UDI-Public: (01)00801741140662
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/08/2025
• Report Date (Section F): 08/08/2025

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: F318108PT
• Device Catalogue Number: F318108PT
• Device Lot Number: REKP2619
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2025
• 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 Age: 76 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Date Report Sent to FDA: 08/08/2025