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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Vestibular autorotation test (vat) to bedside for peripheral intravenous line (piv) placement.Patient difficult iv access.Determined powerglide midline to be placed.20g 10cm powerglide midline placed to left cephalic vein x 1 attempt.While securing device with statlock, powerglide flushed with normal saline (ns) and site noted to be leaking ns.Powerglide removed immediately and new 20g 10cm powerglide midline placed without difficulty (from same lot #).Upon inspection of defective powerglide midline, the catheter tip is almost fully detached at the proximal portion of the hub.

• 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: 19905702
• Report Number: 19905702
• Device Sequence Number: 20617170
• Product Code: FOZ
• UDI-Device Identifier: 00801741140686
• UDI-Public: (01)00801741140686
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/02/2024
• Report Date (Section F): 04/02/2024

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: F320108PT
• Device Catalogue Number: F320108PT
• Device Lot Number: REHY3267
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Male
• Date Report Sent to FDA: 04/02/2024