MAUDE Adverse Event Report: CARDINAL HEALTH ARGYLE YANKAUER FLEXIBLE SUCTION DEVICE; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number UNKNOWN OPERATING ROOM

Device Problem Suction Problem (2170)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

This complaint was received via an anonymous clinical study.Sample analysis could not be performed since samples were not provided for evaluation.This complaint will be used for trending and post market analysis.

Event Description

Per a post market clinical survey, the customer observed device occlusion with the use of an argyle yankauer flexible suction device.This information was received via an anonymous post market clinical study; therefore, the customer information is unknown and no further information will be provided.

Manufacturer Narrative

Corrected the brand name and product code in section d.

• Brand Name: ARGYLE YANKAUER FLEXIBLE SUCTION DEVICE
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17553024
• MDR Text Key: 321250061
• Report Number: 9612030-2023-03792
• Device Sequence Number: 1
• Product Code: GCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: UNKNOWN OPERATING ROOM
• Device Catalogue Number: UNKNOWN OPERATING ROOM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1