MAUDE Adverse Event Report: CARDINAL HEALTH YANKAUER OPEN TIP W ON OFF CN; CATHETER AND TIP, SUCTION

Model Number	8888505172
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2022
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 during orthopedic surgery, the yankauer was used for blood salvage.After the operation they noticed the tip was chipped.There was no effect on the patient and no medical intervention required.
Additional Manufacturer Narrative
The device history record (dhr) review could not be performed because a lot number was not available.A sample analysis could not be performed because no physical sample was available for evaluation.One (1) picture was provided.In the photo, the yankauer tip has a small opening, similar to a crack.The complaint will be reopened if the sample is returned.The reported condition could be confirmed from the picture received.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.The root cause could not be determined without a physical sample to evaluate.A risk assessment was carried out to determine the observed occurrence for the reported failure mode.The observed occurrence is equal the range expected; therefore, no action plan is required at this point.This complaint will be used for tracking and trending purposes.

• Brand Name: YANKAUER OPEN TIP W ON OFF CN
• Common Device Name: CATHETER AND TIP, SUCTION
• 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: 14434277
• Report Number: 9612030-2022-03252
• Device Sequence Number: 5106915
• Product Code: JOL
• UDI-Device Identifier: 10884527020010
• UDI-Public: 10884527020010
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2022

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: 8888505172
• Device Catalogue Number: 8888505172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2022
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 06/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown