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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 381523
Device Problems Fluid Leak (1250); Material Puncture/Hole (1504)
Patient Problem Blood Loss (2597)
Event Date 10/10/2019
Event Type  malfunction  
Event Description
Bd insyte autoguard winged iv catheter 22-gauge x 1 in was found to be infiltrated. When iv was pulled, a small hole was found in the catheter where the blue parts connect to the clear catheter. Bd insyte autoguard winged iv catheter 22-gauge x 1 in was replaced. Patient later hit arm with iv on bedside table. Bloody fluid began leaking from around dressing. Dressing taken off to assess. Only 1/4 cm of the catheter was attached to the hub. Remainder of catheter removed by interventional radiology today. Both believed to be from lot # 9163692.
 
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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 dr
franklin lakes NJ 07417
MDR Report Key9202050
MDR Text Key162635226
Report Number9202050
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 10/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number381523
Device Catalogue Number381523
Device Lot Number9163692
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/11/2019
Event Location Hospital
Date Report to Manufacturer10/17/2019
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

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