MAUDE Adverse Event Report: CARDINAL HEALTH 200, INC. MONOJECT; CANNULA, SURGICAL, GENERAL PLASTIC SURGERY

Model Number 8881540111

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Information (3190)

Event Date 07/27/2018

Event Type  malfunction  

Event Description

A monoject needleless med prep cannula was being prepared for use.The nurse removed the gray-colored cap from the blunt cannula and observed that there were brown and black "spots" (unknown substance) on the cannula.The cannula was removed from the patient care area and sent to the purchasing department for follow-up with our vendor.Follow up: thus far, no other cannulas with spotting have been found.However, inspection of all packaging of cannulas is limited as the clear plastic blunt end is covered with a gray cap.The clear blunt tip (where spotting was located) is not viewable until the gray cap is removed.A report of the event along with a photograph of the cannula were sent to the vendor and their initial response was "not sure what may have caused the issue." they requested that we return the cannula with spots to them so they can investigate the cause of this issue.The cannula will be sent to the vendor per their request.

• Brand Name: MONOJECT
• Type of Device: CANNULA, SURGICAL, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): CARDINAL HEALTH 200, INC.; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 7812426
• MDR Text Key: 118124288
• Report Number: 7812426
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881540111
• Device Catalogue Number: 8881540111
• Device Lot Number: 808717
• 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: 07/31/2018
• Event Location: Other
• Date Report to Manufacturer: 08/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1