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

Model Number	K86
Medical Device Problem Codes	Crack (1135); Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2023
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 the yankauers are cracked, causing loss of suction, also there is a sharp jagged edge along the line of the crack that could cause patient harm during use.Additional information received stated the or noticed the cracks when they tried to use them.Some were plugged, not just cracked.
Additional Manufacturer Narrative
The device history record (dhr) review showed 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.Fifty-three samples were received at the manufacturing site for evaluation.Five were received in opened packaging and forty-eight were received in unopened packages.One of the opened samples had a crack in the curved part of the yankauer, and two of the unopened samples were found to have cracks.The investigation was carried out with the multifunctional team.All processes and controls were found to be followed correctly, including packaging and all inspections performed on the product.No abnormal conditions were found that could trigger the reported condition.No action plan required at this point.Personnel were notified of the reported condition and preventative maintenance was performed.This complaint will be used for tracking and trending purposes.

• Brand Name: SUCTION YANKAUER CLEAR BULB TIP
• 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: 16303149
• Report Number: 9612030-2023-03543
• Device Sequence Number: 12463332
• Product Code: GCX
• UDI-Device Identifier: 00885380030157
• UDI-Public: 00885380030157
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 04/03/2023

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: K86
• Device Catalogue Number: K86
• Device Lot Number: 2224914564
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2023
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown