MAUDE Adverse Event Report: CODAN CODAN LOW VOLUME EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number BC 568

Device Problem Air Leak (1008)

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

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 patient.

• Brand Name: CODAN LOW VOLUME EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CODAN
• MDR Report Key: 7086910
• MDR Text Key: 94143323
• Report Number: MW5073766
• 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: Patient
• Type of Report: Initial
• Report Date: 12/01/2017

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 Model Number: BC 568
• Device Lot Number: 73598
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2017
• 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