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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD INSYTE AUTOGUARD INTRAVASCULAR CATHETER

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BD BD INSYTE AUTOGUARD INTRAVASCULAR CATHETER Back to Search Results
Lot Number 8013892
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 05/22/2018
Event Type  malfunction  
Event Description
A 20 gauge iv cathlon inspected as usual and no visual defects noted. Iv started. As rn was advancing catheter, blood was dripping from small hole at base of cathlon. Iv had to be removed and restarted on pt. The cathlon causes iv fluids to infiltrate into the skin due to the hole being at the point the hub connects to the "straw. " this occurred on another pt and the whole lot of cathlon's was pulled from stock.
 
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Brand NameBD INSYTE AUTOGUARD
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BD
MDR Report Key7553109
MDR Text Key109687754
Report NumberMW5077500
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 05/25/2018
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received05/29/2018
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2020
Device Lot Number8013892
Was Device Available for Evaluation? No Answer Provided
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

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