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U.S. Department of Health and Human Services

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

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BARD ACCESS SYSTEMS, INC. STATLOCK ARTERIAL; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
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.
 
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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 Key11560264
MDR Text Key242026590
Report Number11560264
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
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 NumberART0220
Device Catalogue NumberART0220
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/18/2021
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer03/24/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age26645 DA
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