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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC BD INSYTE AUTOGUARD; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC BD INSYTE AUTOGUARD; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 381512
Device Problem Malposition of Device (2616)
Patient Problem Swelling (2091)
Event Date 08/14/2020
Event Type  malfunction  
Event Description
This rn was attempting to gain iv access on the patient using a 24-gauge lot: 9078797.While advancing the catheter in the vein, this rn saw an obvious rise in elevation under the patient's skin.This rn removed the catheter immediately and noticed that the tip of the catheter was at a 90-degree angle perpendicular to the rest of the catheter.This rn took the set and placed a patient sticker on it and handed it to the cn at the time rn.The patient had to be stuck again in order to obtain access due to the prior default reported above.
 
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Brand Name
BD INSYTE AUTOGUARD
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC
9450 south state street
sandy UT 84070
MDR Report Key10476149
MDR Text Key205110742
Report Number10476149
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 08/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number381512
Device Catalogue Number381512
Device Lot Number9078797
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/27/2020
Date Report to Manufacturer09/01/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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