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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION INC. SOFIA 5F-125CM STR CATHETER, INTRAVASCULAR, DIAGNOSTIC

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MICROVENTION INC. SOFIA 5F-125CM STR CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number DA5125ST
Device Problems Defective Device (2588); Material Twisted/Bent (2981); Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 12/13/2019
Event Type  malfunction  
Event Description
As the provider opened the catheter packaging for use, he noted that the catheter was bent and not usable. The catheter was not used on the patient.
 
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Brand NameSOFIA 5F-125CM STR
Type of DeviceCATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
MICROVENTION INC.
1311 valencia avenue
tustin CA 92780
MDR Report Key9557352
MDR Text Key173923687
Report Number9557352
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/30/2019,12/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDA5125ST
Device Catalogue NumberDA5125ST
Device Lot Number190903138
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/30/2019
Event Location Hospital
Date Report to Manufacturer01/07/2020
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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