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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INSYTE AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BD INSYTE AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number 382523
Device Problems Fluid Leak (1250); Connection Problem (2900)
Patient Problem Insufficient Information (4580)
Event Date 07/27/2021
Event Type  malfunction  
Event Description
Regarding bd insyte autoguard bc 22 gauge 1 inch needles. Piv placed and iv catheter hub did not luer lock into iv extension tubing properly. Iv leaking at this connection site despite changing iv extension tubing. Unable to infuse medication, needed to remove iv to place another patent iv. Patient is a difficult iv start and we were unable to establish another piv at the time and patient needed to be rescheduled.
 
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Brand NameINSYTE AUTOGUARD
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BD
1 becton drive
franklin lakes NJ 07417
MDR Report Key12466686
MDR Text Key271285824
Report Number12466686
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 08/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number382523
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/02/2021
Event Location Outpatient Treatment Facility
Date Report to Manufacturer09/14/2021
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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