MAUDE Adverse Event Report: COVIDIEN YANKAUER OPEN TIP W ON OFF CN; CATHETER AND TIP, SUCTION

Model Number	8888505172
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/08/2020
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.
Event or Problem Description
The customer reported that the yankauer was used during cardiac surgery and it was unable to suction.A second yankauer was opened and used however it was also unable to suction.The fluid reached a little over the bending point of the catheter but would get stuck there.The catheter was used again and the suction pressure was raised but nothing had changed.The yankauer had to be replaced with another makers catheter which suctioned without a problem.It was confirmed that there were no clogs or issues with the tube between the catheter and the aspirator.The tube's shape was a little flattened during suctioning.To verify there were no issues with the tubing the catheter was detached from the tube and the suction with the tube was checked, there were no issues with the tube.The user understands both operation procedure and structure of the black control lever, and those had been checked at the operating field.There was no harm to the patient.
Additional Manufacturer Narrative
Device evaluation: h3: the device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.One decontaminated sample without original package or lot number was received for evaluation.The sample was visually and functionally inspected; however, the reported condition was not confirmed.The device met specifications.All process and controls were found properly followed, including sub-assemblies, finished product assembly and packaging, and inspections performed to the product.There were no abnormal conditions found that could trigger the reported condition and the current process was running according to approved specifications.No corrective actions are deemed necessary.The manufacturing site will continue monitoring the process for any adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• Brand Name: YANKAUER OPEN TIP W ON OFF CN
• Common Device Name: CATHETER AND TIP, SUCTION
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 10543703
• Report Number: 9612030-2020-02616
• Device Sequence Number: 3123842
• Product Code: JOL
• UDI-Device Identifier: 10884527020010
• UDI-Public: 10884527020010
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2021

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: No Information
• Device Model Number: 8888505172
• Device Catalogue Number: 8888505172
• Device Lot Number: 1928827964
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 02/12/2021
• Patient Sequence Number: 1