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

Model Number 8888160333

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 05/04/2017

Event Type  malfunction  

Manufacturer Narrative

Submit date: 09/12/2017 an investigation is currently underway.Upon completion, the results will be forwarded.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states they experienced leakage and / or breakage of the umbilical vessel catheter.

Manufacturer Narrative

A sample was returned for analysis and investigation.The device that was returned was used and had remnants of blood and was placed inside a generic plastic bag.Underwater testing was performed and a leak below the strain relief was identified in the used catheter.Magnified pictures were taken and a tear/hole was observed in the sample.The condition reported e could occur during normal use if there is a leak at the strain relief junction however manufacturing performs a 100% leak testing as per procedure which would identify this issue during the catheter assembly.Based on the sample provided, the catheter was broken in two sections possible causes for the condition are: machine malfunction, unintentional customer misuse, product inspection inadequacy or not performed, or a sharp object was used that came into contact with the catheter are all possibilities.Sharp objects should not be used with a catheter.It is important to consider that the instructions for use warn: exercise caution when using sharp instruments near the catheter.Do not use instruments with sharp or rough edges directly on the catheter since even a minor cut could tear or break the catheter.Do not pinch or bend the catheter back to temporarily occlude the catheter.This causes increased stress on the catheter which can lead to a leak or break.Do not use clamps on umbilical vessel catheters] and continues, do not use alcohol, acetone, or alcohol co ntaining antiseptics directly on the catheter.Carefully check antiseptic solutions for alcohol or acetone.These substances may cause irreversible damage to the polyurethane which can lead to a leak or break.Ensure gloves or other surfaces which have alcohol on them are completely dry before touching or manipulating the catheter.There are a number of alternatives on the field like exposure to chemical agents, proximity to heat sources or manipulation per se, that may lead to tubing tear.Based on the available information, it can be concluded that product was manufactured according to specifications; therefore the most probable root cause can be considered as unintentional misuse; this condition was more likely damaged during use caused due to an improper use / manipulation by the user.It must be noted that in-process controls such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARGYLE
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20, calle #2; alajuela 0101
• Manufacturer (Section G): COVIDIEN; edificio b20, calle #2; alajuela 0101
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6858947
• MDR Text Key: 85806162
• Report Number: 3009211636-2017-05291
• 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: other,user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Device Lot Number: 163200160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1