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

Model Number	F320108PT
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
I was placing a power glide for patient in r [right] basilic.I located vessel and was able to get blood return.I advanced wire without any issues or resistance.I then went to advance catheter.The device split apart at the tip and the catheter would not advance.The patient complained of pain.I attempted to pull device back and at the insertion site, the device was not completely coming out.The skin was being pulled/tugged like the object was larger than the insertion site.

• 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: 24829900
• Report Number: 24829900
• Device Sequence Number: 21137854
• Product Code: FOZ
• UDI-Device Identifier: 00801741140686
• UDI-Public: (01)00801741140686
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 03/30/2026
• Report Date (Section F): 03/30/2026

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: F320108PT
• Device Catalogue Number: F320108PT
• Device Lot Number: REKX0138
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2026
• 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 Age: 77 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Date Report Sent to FDA: 03/30/2026