MAUDE Adverse Event Report: COVIDIEN ARGYLE; VENOUS CATHETER

Model Number 8888160341

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2014

Event Type  malfunction  

Event Description

Tubing was caught between baby's toes and snapped at the base of the venous access.

• Brand Name: ARGYLE
• Type of Device: VENOUS CATHETER
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 3636355
• MDR Text Key: 18811395
• Report Number: 3636355
• Device Sequence Number: 1
• Product Code: DWF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 8888160341
• Device Catalogue Number: 8888160341
• Device Lot Number: 310907X
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 DAY