MAUDE Adverse Event Report: CARDINAL HEALTH ARGYLE ALTITUDE DRY SUCT C D U; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	8888571370
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the closed chest tube drainage system (aqua-seal) showed disconnection without traction.The customer stated that the collection bottle extension (aqua-seal) that connects to the chest drain is made of pvc material.
Additional Manufacturer Narrative
Based on the information available to us, we were unable to confirm the event.The device was not returned for evaluation.Furthermore, the device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process of the reported lot number.In the meantime, all information received will be used for further tracking and trending purposes.

• Brand Name: ARGYLE ALTITUDE DRY SUCT C D U
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; sragh industrial estate, co, t; offaly ; EI
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 19463961
• Report Number: 9611018-2024-00021
• Device Sequence Number: 6653126
• Product Code: GCX
• UDI-Device Identifier: 10884521060975
• UDI-Public: 10884521060975
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 06/18/2024

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: 8888571370
• Device Catalogue Number: 8888571370
• Device Lot Number: 21K187FHX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 06/18/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown