MAUDE Adverse Event Report: COVIDIEN ARGYLE; SINGLE LUMEN UMBILICAL CATHETER

Catalog Number 8888160341

Device Problem Break (1069)

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

Event Date 05/28/2015

Event Type  malfunction  

Event Description

Upon removal of the umbilical catheter, the suture was removed and catheter noted to be broken at 17 cm mark inside the patient's umbilicus.An x-ray was taken.The surgeon made a small incision and removed the remaining catheter fragment.An additional x-ray obtained, demonstrated no retained foreign items.

• Brand Name: ARGYLE
• Type of Device: SINGLE LUMEN UMBILICAL CATHETER
• Manufacturer (Section D): COVIDIEN; 15 hampshire st.; mansfield MA 02048
• MDR Report Key: 4938642
• MDR Text Key: 6252115
• Report Number: 4938642
• Device Sequence Number: 1
• Product Code: JOL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 8888160341
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/19/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2015
• Patient Sequence Number: 1
• Patient Age: 10 DAY