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

Model Number 8888160408

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/16/2020

Event Type  malfunction  

Event Description

Lines being changed on a umbilical vessel catheter (uvc).The 3-way stopcock included in the original argyle uvc tray cracked.The stopcock was swapped out.No untoward patient effects.

• Brand Name: ARGYLE UMBILICAL VESSEL CATHETER TRAY
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 300 south riverside plaza; suite 2010; chicago IL 60606
• MDR Report Key: 10301271
• MDR Text Key: 199673029
• Report Number: 10301271
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888160408
• Device Catalogue Number: 8888160408
• 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: 07/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 7 DA