MAUDE Adverse Event Report: CODAN CODAN LOW VOLUME EXTENSION SET

Model Number BC 568

Device Problems Air Leak (1008); Break (1069); Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 11/30/2017

Event Type  malfunction  

Event Description

Hub for extension set was discovered to be broken at the point the clave was attached.(male connection piece broke off into clave) creating an air bubble that the nurse had to remove to avoid it reaching the pt.

• Brand Name: CODAN LOW VOLUME EXTENSION SET
• Type of Device: CODAN LOW VOLUME EXTENSION SET
• Manufacturer (Section D): CODAN
• MDR Report Key: 7087028
• MDR Text Key: 94143237
• Report Number: MW5073776
• 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: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC 568
• Device Lot Number: 73598
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1