MAUDE Adverse Event Report: COVIDIEN ARGYLE; CATHETER AND TIP, SUCTION

Model Number	8888505164
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported procedure: avr.Product was used with pump oxygenators.It did not aspirated.The customer tested the product after surgery, it was confirmed air leaked from connector between tubing and handle.
Additional Manufacturer Narrative
One decontaminated sample with lot number 629986364x was received for evaluation.After performing an inspection the condition reported was not observed, the product specifications met quality acceptance criteria.The device history record (dhr) file was reviewed indicating that product was released meeting all quality standard requirements.After an evaluation of the sample for the reported leaking in the bonding between the white and clear components of the yankauer and according to the product specification, the bonding between these components is not sealed (only 2 sides out of 4 are sealed with solvent), therefore these products have never been sealed and meet all the product acceptance criteria, form fit and function.The potential failure mode reported by the customer could have been generated by an external factor not related with the device performance.There are no corrective actions deemed necessary at this moment.The process is running according to product specifications meeting quality acceptance criteria.We will continue monitoring the process for any adverse trends that require immediate attention.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARGYLE
• Common Device Name: CATHETER AND TIP, SUCTION
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 1113 cuidad; tijuana,na 22444 ; MX 22444
• MDR Report Key: 6849079
• Report Number: 9612030-2017-05157
• Device Sequence Number: 13631208
• Product Code: JOL
• UDI-Device Identifier: 20884527020000
• UDI-Public: 20884527020000
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2022
• Device Model Number: 8888505164
• Device Catalogue Number: 8888505164
• Device Lot Number: 705889264X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2017
• Supplement Date Received by Manufacturer: 08/17/2017
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 02/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1