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

Model Number BC 564

Device Problems Leak/Splash (1354); Connection Problem (2900)

Patient Problem Pain (1994)

Event Date 02/21/2019

Event Type  malfunction  

Event Description

It has been reported by our anesthesiologists that the codan minibore extention set with male luerlock are difficult to connect to the female luerlock on the perifix continious epidural.This is causing medication to leak from this connection leading to unnecessary labor pain.This patient's pain was able to be controlled after this connection was reinforced by anesthesia.This poor connection must be reinforced frequently to assure that patient's epidurals do not leak.

• Brand Name: CODAN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CODAN US CORPORATION; 3511 west sunflower ave.; santa ana CA 92704
• MDR Report Key: 8394073
• MDR Text Key: 137944213
• Report Number: 8394073
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00813153020005
• UDI-Public: (01)00813153020005
• 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: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BC 564
• Device Catalogue Number: 71.7034
• 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: 02/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other