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	02/17/2023
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.Per additional information provided on (b)(6) 2023, the yankauers were cracked before use but some of them were not noticed until trying to use them.The staff had to open a few of them until they located one that was not affected.There was no patient harm, only a patient safety issue.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured on (b)(6) 2022.A sample was not received for the investigation.Because a sample was not returned, we were unable to perform functional and visual evaluations to confirm the reported condition and determine the root cause.If a sample is received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.Personnel has been made aware of the reported condition.No further action is applicable at this time.Functional testing and visual inspections are performed according to our current quality standards and inspection procedures.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: 16459390
• Report Number: 9612030-2023-03579
• Device Sequence Number: 14051785
• 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,Distributor
• 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
• Operator of Device: Health Professional
• Device Model Number: K86
• Device Catalogue Number: K86
• Device Lot Number: 2224914564
• 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: 02/17/2023
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 03/01/2023
• 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