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

Model Number	8888160358
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
The customer states the umbilical vessel catheter was inserted and the line was found to have resistance with some blood clots found inside the tubing.The medical professionals clamped the line (coated with gauze) with an artery forceps and changed the external accessories (extension tube and three-way stopcock).After releasing the artery forceps, the line was found broken.
Additional Manufacturer Narrative
An investigation was performed for the reported customer complaint: ¿the customer states the umbilical vessel catheter was inserted and the line was found to have resistance with some blood clots found inside the tubing.The medical professionals clamped the line (coated with gauze) with an artery forceps and changed the external accessories (extension tube and three-way stopcock).After releasing the artery forceps, the line was found broken into two pieces.There was no occlusion.¿ a review of the device history record (dhr) for lot number 1712400095 indicated the product was released meeting all quality standards.All dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.One (1) single-lumen umbilical vessel catheter was returned for evaluation.Manufacturing performs 100% leak testing which would ide ntify this issue in the catheter assembly.Visual inspection observed the cannula was severed at the connection.The root cause of the observed damage was determined to be misuse of the product which caused or contributed to the reported condition.The reported customer complaint is confirmed.The root cause was determined to be misuse by the end user.This complaint will be u tilized for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARGYLE
• Common Device Name: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 8229197
• Report Number: 3009211636-2019-00007
• Device Sequence Number: 2267284
• Product Code: FOS
• UDI-Device Identifier: 20884527020529
• UDI-Public: 20884527020529
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/04/2022
• Device Model Number: 8888160358
• Device Catalogue Number: 8888160358
• Device Lot Number: 1712400095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Received by Manufacturer: 12/27/2018
• Supplement Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1