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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 382544
Device Problems Break (1069); Failure to Advance (2524); Detachment of Device or Device Component (2907)
Patient Problem No Code Available (3191)
Event Date 03/04/2020
Event Type  malfunction  
Event Description
18 gauge x 1. 16in iv utilized to gain venous access. Needle penetrated skin superficially, but catheter and needle would not advance farther into vein. No access achieved. Upon withdrawal of needle, rn determined that iv catheter was broken, and a noticeable "chip" broken off of tip of catheter. Pt denies adverse reactions at this time. Visible pinpoint sized puncture on left wrist area.
 
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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
1 becton drive
franklin lakes NJ 07417
MDR Report Key10052088
MDR Text Key190799883
Report Number10052088
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 05/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number382544
Device Catalogue Number382544
Device Lot Number9353663
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/05/2020
Event Location Hospital
Date Report to Manufacturer05/13/2020
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?
Type of Device Usage

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