MAUDE Adverse Event Report: CARDINAL HEALTH, INC. ARGYLE; CATHETER, UMBILICAL ARTERY

Model Number 8888160424

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 05/28/2021

Event Type  malfunction  

Event Description

Rn opened uvc tray for placement in premature infant.Iodine swabstick is to be supplied in the kit and this kit was missing the iodine swabstick.Swabstick was able to be obtained from supply room.

• Brand Name: ARGYLE
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12007906
• MDR Text Key: 256463087
• Report Number: 12007906
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/10/2021

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: No Information
• Device Model Number: 8888160424
• Device Catalogue Number: 8888160424
• Device Lot Number: 2023700129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1