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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 BC 252
Device Problems Leak/Splash (1354); Component Missing (2306)
Patient Problem Discomfort (2330)
Event Date 01/21/2020
Event Type  malfunction  
Event Description
Pediatric patient intubated on continuous infusions of sedation, receiving boluses. Overnight patient was increasingly agitated, rn was bolusing with little effect. The day rn noticed the same pattern. She inspected the iv tubing and extensions and found the iv tubing (quad t-connector extension set) had a lumen missing and the sedation was leaking out of tubing. Tubing changed, patient bolused and was appropriately sedated. Upon inspecting the codan (bc 252) quadfurcated t connector extension set with non-vented caps the attached lumens easily become disconnected. This is a major concern with this product. Inspection of the indicates that the tubing separates from the main hub of the connector extension with little or no pulling, causing the patient not to receive important medication.
 
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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 Key9659555
MDR Text Key177399284
Report Number9659555
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBC 252
Device Catalogue Number76.8089
Device Lot Number79841
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/28/2020
Event Location Hospital
Date Report to Manufacturer02/03/2020
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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