MAUDE Adverse Event Report: CARDINAL HEALTH, INC. ARGYLE; TUBING, NONINVASIVE

Model Number	8888301515
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Missing blue connector.

• Brand Name: ARGYLE
• Common Device Name: TUBING, NONINVASIVE
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 15 hampshire street building 5; mansfield MA 02048
• MDR Report Key: 10413154
• Report Number: 10413154
• Device Sequence Number: 14340586
• Product Code: GAZ
• UDI-Device Identifier: 10884527019601
• UDI-Public: (01)10884527019601
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2020
• Report Date (Section F): 08/05/2020

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
• Operator of Device: No Information
• Device Model Number: 8888301515
• Device Catalogue Number: 8888301515
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/17/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/17/2020
• 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: 08/05/2020