MAUDE Adverse Event Report: CARDINAL HEALTH, INC. ARGYLE; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	461008E
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Rn opened 5fr ng tube for placement in nicu patient.Upon inspection for measurement, rn noted that the tube was missing the printed markings on the tube.Tubing and packaging was saved and new tube was obtained and used.The device was never used on patient.It was found prior to use on infant.

• Brand Name: ARGYLE
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 15 hampshire street building 5; mansfield MA 02048
• MDR Report Key: 9847361
• Report Number: 9847361
• Device Sequence Number: 2373171
• Product Code: PIF
• UDI-Device Identifier: 10884521547230
• UDI-Public: (01)10884521547230
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/27/2020
• Report Date (Section F): 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 461008E
• Device Catalogue Number: 461008E
• Device Lot Number: 1824727264
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/27/2020