MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. STATLOCK ARTERIAL; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	ART0420
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Registered nurse (rn) noticed arterial line wave form appeared flat on monitor.Rn assessed the arterial line and noticed blood coming from the j loop.The lines team was called to assess and noted the tubing was cracked.The tubing was changed.No known patient harm at this time.

• Brand Name: STATLOCK ARTERIAL
• 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: 19837400
• Report Number: 19837400
• Device Sequence Number: 20787468
• Product Code: FPA
• UDI-Device Identifier: 00801741081354
• UDI-Public: (01)00801741081354
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/22/2024
• Report Date (Section F): 05/22/2024

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: ART0420
• Device Catalogue Number: ART0420
• Device Lot Number: JUJN8594
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 07/26/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/22/2024