MAUDE Adverse Event Report: COVIDIEN LP ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION TRAY; UMBILICAL ARTERY CATHETER

Model Number 8888160424

Device Problems Fluid/Blood Leak (1250); Defective Component (2292)

Patient Problem No Information (3190)

Event Date 06/17/2017

Event Type  malfunction  

Event Description

Umbilical venous catheter was placed in infant.Immediately upon going to use the line, the nurse noticed that there was a defect and that the line was leaking (where line meets the hub).Device was removed immediately.

• Brand Name: ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION TRAY
• Type of Device: UMBILICAL ARTERY CATHETER
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 6676471
• MDR Text Key: 78678766
• Report Number: 6676471
• 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: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 06/30/2019
• Device Model Number: 8888160424
• Device Catalogue Number: 8888160424
• Device Lot Number: 1708800127
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/22/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTHER, PATIENT WAS VENTILATED AT THE TIME OF THE
• Patient Weight: 1