MAUDE Adverse Event Report: COVIDIEN MANUFACTURING SOLUTIONS SA; CATHETER, UMBILICAL ARTERY

Lot Number 1521687

Device Problem Leak/Splash (1354)

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

Event Date 09/30/2018

Event Type  malfunction  

Event Description

Leaking umbilical catheter 5 french single lumen.

• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN MANUFACTURING SOLUTIONS SA; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8334697
• MDR Text Key: 136016931
• Report Number: 8334697
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/07/2019,10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 1521687
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2019
• Date Report to Manufacturer: 02/13/2019
• Type of Device Usage: N
• Patient Sequence Number: 1