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

Model Number	8888505016
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that upon opening a package of material, they discovered two cannulas with fissures.There was no harm reported.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) for lot number 2507007364 was reviewed and no anomalies related to the reported issue were observed.Two samples were received for evaluation.During visual inspection, a few lines were observed on the yankauer.Upon functional evaluation (leak test), a crack was identified in one of the two samples.A gemba walk was performed to review the manufacturing process.The process and controls were found properly followed, including sub-assemblies, finished product assembly, packaging, and inspections performed to the product.In addition, quality control inspections are performed to the product for material release which include a visual inspection sampling to verify the correct assembly of device, as well as a 100% visual inspection performed by personnel production during the process, in order to detect and discard any identified issues.Based on all available information, a definitive root cause could not be determined at this time.As part of continuous improvements, a quality alert has been created.No corrective actions are warranted at this time.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: ARGYLE
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 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: 23732335
• Report Number: 1423537-2025-00491
• Device Sequence Number: 9751726
• Product Code: GCX
• UDI-Device Identifier: 10192253038996
• UDI-Public: (01)10192253038996(17)300228(10)2507007364
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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: 8888505016
• Device Catalogue Number: 8888505016
• Device Lot Number: 2507007364
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 03/25/2026
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown