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

Model Number BC 263

Device Problems Defective Device (2588); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/19/2017

Event Type  malfunction  

Event Description

New tubing, packaging all intact, however, tubing would not flush.There appears to be a defect in which the tubing is crimped internally.

• Brand Name: CODAN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CODAN US CORP.; 3511 west sunflower ave.; santa ana CA 92704
• MDR Report Key: 6510720
• MDR Text Key: 73348971
• Report Number: 6510720
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 06/01/2019
• Device Model Number: BC 263
• Device Catalogue Number: 72.8016
• Device Lot Number: 78747
• Other Device ID Number: REGULAR BORE EXTENSION SET WI
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2017
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1