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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODAN US CORP. EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR

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CODAN US CORP. EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 72.8009
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem Insufficient Information (4580)
Event Date 08/28/2020
Event Type  malfunction  
Event Description
An area of an iv extension set was found to be cut and opened. It was brand new out of the package and packaging was not altered in any way. Fda safety report id# (b)(4).
 
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Brand NameEXTENSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CODAN US CORP.
santa ana CA 92704
MDR Report Key10527615
MDR Text Key206955976
Report NumberMW5096566
Device Sequence Number1
Product Code FPA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72.8009
Device Lot Number78518
Was Device Available for Evaluation? Yes
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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