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

Model Number 8888505040

Device Problem Scratched Material (3020)

Patient Problem Ulcer (2274)

Event Type  No Answer Provided  

Event Description

I am an anesthesiologist and have had 3 patients end up with wounds in the back of their mouths after using this suction tip.The first 2 patients i did not realize how dangerous it was.The 3rd patient, i very gingerly used the suction tip prior to extubating the patient.The suction tip has holes on the sides near the tip that are cut so that the edges of the holes are sharp.You can feel the sharp edges with your finger and fingernail.I have shown the suction tip to an ent surgeon i work with and he replied "this should not to placed anywhere in the human body".I have attached pictures of the packaging material as well as a closeup of the tip of the suction tip.

• Brand Name: ARGYLE
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC
• MDR Report Key: 12562138
• MDR Text Key: 275154168
• Report Number: MW5104324
• Device Sequence Number: 2
• Product Code: GCX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 8888505040
• Device Catalogue Number: 8888505040
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1