MAUDE Adverse Event Report: CARDINAL HEALTH YANKAUER OPEN W/O TROL; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	8888505115
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported during a cardiac surgery intervention under cec, when using the suction cannula, it broke at the tip and caused a coronary sinus injury.This resulted in additional procedures being carried out during the operation, and therefore longer bypass surgery for the patient.The injury was brought under control by the surgeon.Possible lot numbers are 2312925864 or 2312925964.
Additional Manufacturer Narrative
The lot number reported was unknown, however the customer stated it could possibly be lot 2312925864 or 2312925964.A device history record review was conducted for both lots and showed that manufacturing and inspections of the product were performed per procedure.All inspection results were within acceptable criteria as per the established sampling plan levels.In addition, there were no nonconformance reports opened during the manufacturing of these two lots.The customer did not return the device for evaluation; therefore, the reported issue could not be confirmed.A review of our current manufacturing processes was completed and there were no conditions identified that could have contributed to the reported issue.

• Brand Name: YANKAUER OPEN W/O TROL
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 19536501
• Report Number: 1423537-2024-00040
• Device Sequence Number: 6425358
• Product Code: GCX
• UDI-Device Identifier: 10884527019984
• UDI-Public: 10884527019984
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 8888505115
• Device Catalogue Number: 8888505115
• Device Lot Number: UNKNOWN
• 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: 06/05/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 07/25/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown