MAUDE Adverse Event Report: CARDINAL HEALTH, INC. ARGYLE; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	8888501031
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
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 that during routine mouthcare, while suctioning the patient with a yankauer, the tip of the yankauer came off.The sump tip was what broke off the product.The piece was lost in the patient's oropharynx and unable to retrieve or visualize it.Additional information was received from the customer and stated that the patient was already scheduled for an endoscopic procedure, so a plan was made to look for the tip during that procedure.During the procedure, it was unable to visualize the tip in the oropharynx.The endoscopic procedure was already scheduled for another underlying condition, and not specific to the tip removal.The patient passed away on (b)(6) of 2025.Per customer, at this time, they are unable to confirm or exclude correlation between the device malfunction and patient¿s death.
Additional Manufacturer Narrative
The device history record (dhr) for lot number 2304500864 was reviewed and no anomalies related to the reported issue were observed.The physical device was received for evaluation and the reported condition was observed; however, a definitive root cause could not be determined.Based on this information, no corrective actions are warranted at this time.Manufacturing personnel were notified of this complaint for awareness, and we will continue to track and trend through our monitoring programs and take actions as applicable.

• Brand Name: ARGYLE
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 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: 22015180
• Report Number: 1423537-2025-00201
• Device Sequence Number: 9484213
• Product Code: GCX
• UDI-Device Identifier: 10884527019854
• UDI-Public: (01)10884527019854(10)2304500864
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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: 8888501031
• Device Catalogue Number: 8888501031
• Device Lot Number: 2304500864
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American