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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 LESS THAN 30 DAYS

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BECTON, DICKINSON AND COMPANY INSYTE AUTOGUARD CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number 381423
Device Problem Retraction Problem (1536)
Patient Problems Hemorrhage/Bleeding (1888); Needle Stick/Puncture (2462)
Event Date 08/15/2018
Event Type  malfunction  
Event Description
Rn was inserting iv into patients left arm. Rn obtained access with bd insyte autoguard. Clicked button to retract needle, device clicked, rn pulled iv out laid on bed assuming needle retracted, grabbed extension tubing while connecting tubing and flushing iv felt a poke on distal right thigh noted iv insertion needle didn't retract and punctured self, bleeding.
 
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Brand NameINSYTE AUTOGUARD
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
9450 south state street
sandy UT 84070
MDR Report Key7836610
MDR Text Key118880140
Report Number7836610
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 08/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number381423
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/27/2018
Event Location Hospital
Date Report to Manufacturer08/31/2018
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

Patient Treatment Data
Date Received: 08/31/2018 Patient Sequence Number: 1
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