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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. Peripheral Catheter Insertion Kit CATHETER, INTRAVASCULAR

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BARD ACCESS SYSTEMS, INC. Peripheral Catheter Insertion Kit CATHETER, INTRAVASCULAR Back to Search Results
Model Number AC0202250
Device Problems Difficult to Remove (1528); Retraction Problem (1536)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 08/27/2019
Event Type  malfunction  
Event Description
Patient required an ultrasound iv. Accucath was chose to be placed. Iv catheter worked well with insertion into vessel under ultrasound guidance and blood return was noted. The guide wire was threaded without any resistance, along with the catheter into the vessel. Once completed the retraction button was pressed to evacuate the needle and guide wire; the wire became tight and would not retract out of the catheter. Unable to easily remove catheter from patient's arm. The needle, guide wire, and catheter were all removed with no retained objects in patient's arm. The patient was bleeding from site, but stopped with application of coban dressing.
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Brand NamePeripheral Catheter Insertion Kit
Manufacturer (Section D)
605 north 5600 west
salt lake city UT 84116
MDR Report Key8989938
MDR Text Key157366466
Report Number8989938
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAC0202250
Device Catalogue NumberAC0202250
Device Lot NumberREDR3247
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/27/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/27/2019
Event Location Hospital
Date Report to Manufacturer09/11/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/11/2019 Patient Sequence Number: 1