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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,THERAPEUTIC,SHORT-TERM LESS THAN 30

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BARD ACCESS SYSTEMS, INC. PERIPHERAL CATHETER INSERTION KIT CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 Back to Search Results
Model Number AC0202250
Device Problem Failure to Advance (2524)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/04/2020
Event Type  malfunction  
Event Description
The nurse was unable to thread the catheter guidewire, despite the ultrasound confirmation that the needle tip was in the vein. The iv angiocath advanced without difficulty, but the full length of the catheter would not advance. Approximately 50% of the catheter remained external; it was discontinued. After assessing the needle, the nurse noticed the guidewire was protruding from the side of the needle, opposed to the end of the needle.
 
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Brand NamePERIPHERAL CATHETER INSERTION KIT
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
605 north 5600 west
salt lake city UT 84116
MDR Report Key10690068
MDR Text Key211669582
Report Number10690068
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 Risk Manager
Type of Report Initial
Report Date 10/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAC0202250
Device Catalogue NumberAC0202250
Device Lot NumberREES1528
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/05/2020
Event Location Hospital
Date Report to Manufacturer10/16/2020
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 Unkown

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