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

Model Number K86V

Device Problem Suction Failure (4039)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 314896778
• Report Number: 9612030-2023-03694
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 00885380028710
• UDI-Public: 00885380028710
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Initial Date Manufacturer Received: 05/01/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 05/01/2023
• Supplement Dates FDA Received: 08/01/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1