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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEM, INC. BD INSYTE AUTOGUARD BC

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BECTON DICKINSON INFUSION THERAPY SYSTEM, INC. BD INSYTE AUTOGUARD BC Back to Search Results
Catalog Number 382533
Device Problems Break (1069); Mechanical Problem (1384); Material Twisted/Bent (2981)
Patient Problem No Code Available (3191)
Event Date 08/09/2018
Event Type  malfunction  
Event Description
On first attempt, iv catheter bent when being advanced. Vein blew. Upon inspection of the angiocath, it appeared damaged near the end of the tube. On second attempt, vein appeared to blow while trying to advance the catheter. When catheter was removed and inspected, the end of the hub appeared to have been spitting.
 
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Brand NameBD INSYTE
Type of DeviceAUTOGUARD BC
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEM, INC.
sandy UT 84070
MDR Report Key7784411
MDR Text Key117292090
Report NumberMW5079150
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2021
Device Catalogue Number382533
Device Lot Number8102501
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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