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

Lot Number 76837

Device Problems Difficult to Remove (1528); Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 04/11/2022

Event Type  malfunction  

Event Description

"the end of the transplant turkey foot (tri-fuse) tubing connector was retained in patient's blue lumen after autologous transplant was complete.Central line was double-clamped, and capped.Provider was notified and nurse manager was involved.Sterile attempts were made to remove part, but were unsuccessful.Patient was sent to ir to replace/exchange line.".

• Brand Name: CODAN TRIFURCATED EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CODAN US CORPORATION; 3501 west sunflower ave; santa ana CA 92704
• MDR Report Key: 14371087
• MDR Text Key: 291485674
• Report Number: 14371087
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 76837
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/03/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1