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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE-N AUTOGUARD WINGED ANGIOCATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE-N AUTOGUARD WINGED ANGIOCATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 381511
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/01/2021
Event Type  Injury  
Event Description
When piercing the skin, the top of the catheter sheared away from the stylet and slid on top of the skin. The catheter never entered the vein. The stylet was removed from the puncture, was intact and was discarded. No equipment remained in the site. Pressure was held at the failed site and a new identical device was used to start an iv in a different anatomical location. No harm to the patient other than needing stuck a second time. Fda safety report id # (b)(4).
 
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Brand NameINSYTE-N AUTOGUARD WINGED ANGIOCATHETER
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
sandy UT 84070
MDR Report Key11854799
MDR Text Key251943315
Report NumberMW5101436
Device Sequence Number1
Product Code FOZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number381511
Device Lot Number0265013
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/19/2021 Patient Sequence Number: 1
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