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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 382533
Device Problem Structural Problem (2506)
Patient Problem No Patient Involvement (2645)
Event Date 06/02/2019
Event Type  malfunction  
Event Description
The nurse found plastic part of the bd insyte autoguard catheter had a small burr near the end of the catheter.It was never used on a patient.While later examining the catheter, part of the burr was rubbed off, but you can still feel a rough spot on the catheter.The catheter was turned into risk management.
 
Event Description
The nurse found plastic part of the bd insyte autoguard catheter had a small burr near the end of the catheter.It was never used on a patient.While later examining the catheter, part of the burr was rubbed off, but you can still feel a rough spot on the catheter.The catheter was turned into risk management.
 
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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 AND COMPANY
9450 s. state street
sandy UT 84070
MDR Report Key8735177
MDR Text Key149217493
Report Number8735177
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903825332
UDI-Public(01)00382903825332
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 06/05/2019
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 Number382533
Device Catalogue Number382533
Device Lot Number8360633
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/05/2019
Event Location Hospital
Date Report to Manufacturer06/26/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/26/2019
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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