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 Type  malfunction  

Manufacturer Narrative

Submit date: 4/19/2018.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.

Event Description

The customer reports cracks have been observed.

Manufacturer Narrative

An investigation was performed for the reported customer complaint: ¿the customer reports cracks have been observed.¿ the device history record (dhr) for the reported lot number 1523900126 indicates product and specification requirements were met with no non-conforming product identified relating to this customer report.A lot cannot be released unless it passes all quality and conformance requirements.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.During the manufacturing process, catheters are submitted to 100% pressure testing which would identify this reported issue in the catheter assembly.Based on available information, it can be concluded the product was manufactured according to specifications.No product/sample was provided for evaluation.No additional information, pictures or videos were received.Therefore, a comprehensive investigation was unable to be conducted.The reported customer complaint is unable to be confirmed.A root cause could not be determined.This complaint will be utilized 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 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: 7445052
• MDR Text Key: 106026130
• Report Number: 3009211636-2018-00120
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 20884527005113
• UDI-Public: 20884527005113
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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,Followup
• Report Date: 09/19/2018

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: 07/27/2020
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Device Lot Number: 1523900126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/19/2018
• Supplement Dates Manufacturer Received: 03/26/2018
• Supplement Dates FDA Received: 09/19/2018
• Date Device Manufactured: 08/27/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1