MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. PERIPHERAL CATHETER INSERTION KIT; MIDLINE CATHETER

Model Number	ST018101D
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
In the process of placing a bard powerglide midline, a malfunction occured.The catheter is designed to be inserted over a wire.Several attempts to thread the catheter over the wire were unsuccessful.A second full sterile kit needed to be opened and the procedure was completed successfully.

• Brand Name: PERIPHERAL CATHETER INSERTION KIT
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 25373795
• Report Number: 25373795
• Device Sequence Number: 21474877
• Product Code: PND
• UDI-Device Identifier: 00801741139390
• UDI-Public: (01)00801741139390
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 05/28/2026
• Report Date (Section F): 05/28/2026

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
• Device Model Number: ST018101D
• Device Catalogue Number: ST018101D
• Device Lot Number: RELN1691
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 06/03/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2026
• 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: 36 YR
• Patient Sex: Female
• Date Report Sent to FDA: 05/28/2026