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 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

Submit date: 5/1/2018.The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.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 reported a 5 fr umbilical catheter leaked and had to be removed and replaced.

• 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: 7476619
• MDR Text Key: 107193143
• Report Number: 3009211636-2018-00133
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 10884527005116
• UDI-Public: 10884527005116
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2022
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Device Lot Number: 1719300058
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/10/2018
• Date Device Manufactured: 07/13/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1