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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 381434
Device Problems Retraction Problem (1536); Device Fell (4014)
Patient Problem Needle Stick/Puncture (2462)
Event Date 03/25/2019
Event Type  malfunction  
Event Description
Rn inserting 20g insyte. Once iv catheter advanced prior to fully removing needle from catheter, rn decompressed retracting needle, as per usual work flow. Then rn fully removed needle from catheter and decompressed retracting button, button remained decompressed, needle did not retract. Rn laid needle on bed while securing iv, patient moved leg, needle fell off bed and needle stuck into the top of the rns foot first passing through his shoe. Rn pulled needle out of top of shoe and foot.
 
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Brand NameBD INSYTE AUTOGUARD
Type of DeviceCATHETER,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 Key8603392
MDR Text Key144834024
Report Number8603392
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 04/18/2019,04/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number381434
Device Catalogue Number381434
Device Lot Number8337693
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/18/2019
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer05/13/2019
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/13/2019 Patient Sequence Number: 1
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