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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY INSYTE AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BECTON, DICKINSON AND COMPANY INSYTE AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 381412
Device Problems Collapse (1099); Entrapment of Device (1212); Failure to Advance (2524)
Patient Problem Insufficient Information (4580)
Event Date 03/15/2021
Event Type  malfunction  
Event Description
When removing iv catheter from package, prior to starting iv, the iv needle was already collapsed. The needle shield from the tip of the needle was lodged in the end of the iv catheter. Another iv catheter opened. Needle and catheter correct upon inspection. Unable to advance iv needle into arm. Immediately withdrew needle and iv catheter. Upon inspection, needle shield from the tip of needle was lodged in the end of the catheter. Entire lot of 24 ga x 0. 75 in iv catheters removed from med room and given to manager. Management informed of incident.
 
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Brand NameINSYTE AUTOGUARD
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
1 becton drive
franklin lakes NJ 07417
MDR Report Key11648120
MDR Text Key244892683
Report Number11648120
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 03/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number381412
Device Catalogue Number381412
Device Lot Number0336867
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/26/2021
Event Location Outpatient Treatment Facility
Date Report to Manufacturer04/12/2021
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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