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U.S. Department of Health and Human Services

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

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CODAN US CORP. CODAN FLOWSTOP CAP SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number BC566
Device Problem Cut In Material (2454)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/17/2018
Event Type  malfunction  
Event Description
The tubing was noted to be already cut through when the packaging was opened.
 
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Brand NameCODAN FLOWSTOP CAP
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CODAN US CORP.
3511 west sunflower ave.
santa ana CA 92704
MDR Report Key7285251
MDR Text Key100563112
Report Number7285251
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 02/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBC566
Device Catalogue Number71.7018
Device Lot Number74964
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/14/2018
Event Location Hospital
Date Report to Manufacturer02/14/2018
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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