MAUDE Adverse Event Report: COVIDIEN MANUFACTURING SOLUTIONS SA ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER; UMBILICAL CATHETER ARTERY

Model Number REF8888160333

Device Problem Defective Device (2588)

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

Event Date 06/05/2018

Event Type  malfunction  

Event Description

Defective catheter.

• Brand Name: ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER
• Type of Device: UMBILICAL CATHETER ARTERY
• Manufacturer (Section D): COVIDIEN MANUFACTURING SOLUTIONS SA
• MDR Report Key: 7689252
• MDR Text Key: 114088597
• Report Number: MW5078377
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: REF8888160333
• Device Catalogue Number: 8888160333
• Device Lot Number: 1708100095
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1