MAUDE Adverse Event Report: CARDINAL HEALTH CLEAR YANKAUER,BULB TIP,VENTED; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	K86V
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
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 on (b)(6) 2023 the patient became less responsive.Rrt was called and suction set up was completed and accurate, but no suction was achieved through the yankauer.The regulator was switched but again no suction.Crash cart suction was then set up by nursing with the same result.Rt now present and advises to try a new yankauer which was effective.
Additional Manufacturer Narrative
The device history record (dhr) could not be reviewed because a lot number was not available.Two digital images were received for evaluation.The reported condition was visually confirmed; the product is cracked.The root cause could not be determined without a physical sample.All process and controls were found properly followed.Based on the investigation, no action plan is required at this point.A quality alert was generated, and staff were notified of the reported condition with the purpose of raising awareness.This complaint will be used for tracking and trending purposes.

• Brand Name: CLEAR YANKAUER,BULB TIP,VENTED
• 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: 16901760
• Report Number: 9612030-2023-03694
• Device Sequence Number: 5458990
• Product Code: GCX
• UDI-Device Identifier: 00885380028710
• UDI-Public: 00885380028710
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2023

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
• Device Model Number: K86V
• Device Catalogue Number: K86V
• 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: 05/01/2023
• Supplement Date Received by Manufacturer: 05/01/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 08/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown