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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODAN US CORPORATION CODAN SET, ADMINISTRATION, INTRAVASCULAR

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CODAN US CORPORATION CODAN SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number A 3002-W
Device Problem Kinked (1339)
Patient Problem No Information (3190)
Event Date 05/28/2018
Event Type  malfunction  
Event Description
Defective tubing noted with kink in the filter section.
 
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Brand NameCODAN
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CODAN US CORPORATION
3511 west sunflower ave.
santa ana CA 92704
MDR Report Key7624645
MDR Text Key111994978
Report Number7624645
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 06/05/2018,06/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2021
Device Model NumberA 3002-W
Device Lot Number72730
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/05/2018
Event Location Hospital
Date Report to Manufacturer06/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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