MAUDE Adverse Event Report: CARDINAL HEALTH FLEXIBLE YANKAUER REGULAR CAPA; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	8888501015
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that one of the nurses was using the covidien yankauer and the tip of the device came off and the patient almost aspirated on it.Additional information was received from the customer and stated that they were doing oral care and the patient was unable to follow direction, needed suctioning.The nurse inserted yankauer into left cheek to suction and when removed, tip was not present.The respiratory therapist (rt) and registered nurse (rn) assisted to keep patient calm and help open the mouth to allow the other rn to look for tip and retrieve.The nurse was able to retrieve the tip from patient¿s posterior aspect of the oral cavity near the oropharynx.Per customer, tongue depressor, flashlight and tweezers were used to retrieve the tip.There was no medical intervention or treatment required because of the incident.
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A physical sample was not received for the evaluation; however, a picture was provided and upon reviewing the picture the reported issue is confirmed.A gemba walk was carried out in the manufacturing area with the multifunctional team.The possible root cause of the reported issue could be related to the missing solvent.As an action plan, the standard work instruction will be updated.At this time, a corrective and preventive action is not deemed necessary.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: FLEXIBLE YANKAUER REGULAR CAPA
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 16958095
• Report Number: 9612030-2023-03703
• Device Sequence Number: 5580801
• Product Code: GCX
• UDI-Device Identifier: 10884527019830
• UDI-Public: 10884527019830
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2023

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 Model Number: 8888501015
• Device Catalogue Number: 8888501015
• Device Lot Number: 2220305264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown