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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INSYTE AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BD INSYTE AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 382533
Device Problem Fluid/Blood Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 07/22/2022
Event Type  malfunction  
Event Description
Patient was having ct with contrast when iv infiltrated. Testing was stopped immediately at the time of infiltration, and iv was removed.
 
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Brand NameBD INSYTE AUTOGUARD
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
MDR Report Key15111623
MDR Text Key296700283
Report Number15111623
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903825332
UDI-Public(01)00382903825332
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 07/26/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number382533
Device Catalogue Number382533
Device Lot Number1257561
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/26/2022
Device Age2 MO
Event Location Hospital
Date Report to Manufacturer07/27/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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