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U.S. Department of Health and Human Services

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

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BECTON, DICKINSON AND COMPANY BD INSYTE AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 381434
Device Problems Failure to Advance (2524); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/04/2019
Event Type  malfunction  
Event Description
Registered nurse (rn) attempted to place an iv in on a teen patient today and the catheter bent at the end. Rn had to remove the catheter. This is the third time that rn has had issue with the end of the catheter on size 20 gauge iv bending and not allowing rn to advance the catheter forward.
 
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Brand NameBD INSYTE AUTOGUARD
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
9450 south state street
sandy UT 84070
MDR Report Key8273162
MDR Text Key133939412
Report Number8273162
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 01/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number381434
Device Catalogue Number381434
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/07/2019
Event Location Hospital
Date Report to Manufacturer01/24/2019
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: 01/24/2019 Patient Sequence Number: 1
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