MAUDE Adverse Event Report: CARDINAL HEALTH AQUA SEAL DUAL DRAIN CDU; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	8888571406
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the pacu rn paged to make them aware that the ¿suction port was loose and had to be taped down to hold suction¿.This was the first occurrence.The scrub tech did not notice any irregularities/defects upon filling the suction chamber prior to connecting the chest tubes.Upon removing the suction tubing from the port the next morning (assessing for air leak), the port was dislodging and attached to the suction tubing in which the doctor decided to leave the patient on water seal only instead of changing the complete system.Additional information received on 14jun2023 stated that the issue occurred while in use and caused diminished suction.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.

• Brand Name: AQUA SEAL DUAL DRAIN CDU
• 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: 17164583
• Report Number: 9611018-2023-00596
• Device Sequence Number: 17578775
• Product Code: GCX
• UDI-Device Identifier: 10884521061002
• UDI-Public: 10884521061002
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 07/28/2023

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
• Operator of Device: Health Professional
• Device Model Number: 8888571406
• Device Catalogue Number: 8888571406
• 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: 06/13/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 07/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown