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

Model Number	461008E
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The infant was receiving ng tube feeding.Upon assessment rn noticed crib sheet was wet and leaking at hub of ng tube.Upon inspection noticed crack at hub.Ng tube was removed and new one placed.Breast milk that was in syringe was discarded due to risk for infection on premature infant.

• Brand Name: ARGYLE
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9852863
• Report Number: 9852863
• Device Sequence Number: 2786985
• 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): 02/11/2020
• Report Date (Section F): 02/11/2020

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 DA
• Patient Weight: 2
• Date Report Sent to FDA: 02/11/2020