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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
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BECTON, DICKINSON AND COMPANY INSYTE AUTOGUARD; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM Back to Search Results
Lot Number ALL LOTS
Device Problems Difficult to Insert (1316); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Patient Problems Extravasation (1842); Hematoma (1884); Infiltration into Tissue (1931)
Event Date 04/05/2022
Event Type  malfunction  
Event Description
Our institution transitioned to the bd insyte autoguard iv catheters and are having the following issues/concerns: catheter bends when trying to break the skin (using technique given by rep).Catheter hub spins when trying to advance catheter so you lose the only piece to advance catheter.Catheter hubs are excessively long making it difficult to place foam appropriately to protect skin, most times catheter is lost or dislodged.Multiple blown veins due to catheter placement struggles.More sticks than normal due catheter issues- greatly impacting patient care and satisfaction.More iv infiltrates/ extravasations during ct scan injections.Some units have already had the bd rep back to the unit for troubleshooting technique and unfortunately this has been ineffective at this time.
 
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Brand Name
INSYTE AUTOGUARD
Type of Device
CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
one becton drive
franklin lakes NJ 07417
MDR Report Key14134935
MDR Text Key289438422
Report Number14134935
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 Other Health Care Professional
Type of Report Initial
Report Date 04/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot NumberALL LOTS
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/05/2022
Event Location Hospital
Date Report to Manufacturer04/18/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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