MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	K86
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The bulbous tip of the yankauer suction handle broke off in femoral canal.Unable to remove.

• Brand Name: CARDINAL HEALTH
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 15454372
• Report Number: 15454372
• Device Sequence Number: 6842578
• Product Code: GCX
• UDI-Device Identifier: 00885380030157
• UDI-Public: (01)00885380030157
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/29/2022
• Report Date (Section F): 08/29/2022

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
• Operator of Device: Other
• Device Model Number: K86
• Device Catalogue Number: K86
• Device Lot Number: 2208302664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 08/29/2022