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

Model Number 8888160333

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 01/26/2018

Event Type  malfunction  

Manufacturer Narrative

Submit date: 3/29/2018.A device history review revealed no discrepancies that may have contributed to a complaint of this failure mode.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements.In addition, all dhr are reviewed for accuracy prior to product release.The physical sample involved in the reported incident was not returned for evaluation.Two photos were provided by the customer.Visual evaluations of these photos were performed and is not possible confirm leak with the photo.Additionally, the catheter shows signs of use (adhesive plaster tape between the tubing and strain relief).An ishikawa diagram was used to determine the potential causes for this event.Based on the investigation, the reported issue could not be confirmed.The product sample was not returned to the manufacturing site for review.According the picture is not possible confirm leak.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 misuse; this defect was most likely damaged during use caused due to an inappropriate 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 oper ations.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports three units present perforation during use.The leak is present just below the molded strain relief on the extension(s).

• 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: 7382339
• MDR Text Key: 103939221
• Report Number: 3009211636-2018-00096
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 10884527005116
• UDI-Public: 10884527005116
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2022
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Device Lot Number: 1707400164
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2018
• Initial Date FDA Received: 03/29/2018
• Date Device Manufactured: 03/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1