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

Model Number ART0220

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/19/2021

Event Type  malfunction  

Event Description

The patient had a radial arterial line for hemodynamic monitoring, and the arterial luer lock spontaneously broke from the tubing.The patient's arterial line alarm sounded, and staff were able to respond, apply manual pressure and prevent further significant bleeding.No known cause for the breakage.

• Brand Name: STATLOCK ARTERIAL
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 11560264
• MDR Text Key: 242026590
• Report Number: 11560264
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/18/2021

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 Operator: No Information
• Device Model Number: ART0220
• Device Catalogue Number: ART0220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2021
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA