MAUDE Adverse Event Report: COVIDIEN ARGYLE; CATHETER, UMBILICAL ARTERY

Model Number 8888160333

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2018

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports that an umbilical vessel catheter (uvc) was leaking after insertion.The customer further reports that there was no patient harm as a result of the incident.

• Brand Name: ARGYLE
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20, calle #2; alajuela 20101
• Manufacturer (Section G): COVIDIEN; edificio b20, calle #2; alajuela 20101
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7349879
• MDR Text Key: 102796842
• Report Number: 3009211636-2018-00082
• 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: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2021
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Device Lot Number: 1620900121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Date Manufacturer Received: 02/19/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/11/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1