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

Model Number	8888571562
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2024
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 when the wall vacuum was connected, the blue liquid contained in the patient manometer compartment spilled into the "underwater safety" compartment.The two compartments began to bubble and the vacuum was not created.Blue liquid was also found on the underside of the chest drainage unit (cdu).The cdu was therefore changed and another cdu from the same batch was plugged in and worked without a problem.There was no patient harm reported.The cdu was not kept because it was soiled.
Additional Manufacturer Narrative
Based on the information available to us, we were unable to confirm the event.A physical sample was not returned for evaluation.Photos were provided and reviewed; there is blue liquid seen on the foot stand, but there is no evidence of the blue liquid spilled into the "underwater safety" compartment.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.A quality alert has been issued to the manufacturing line to ensure they are aware of this complaint.In the meantime, all information received will be used for further tracking and trending purposes.

• Brand Name: SENTINEL SEAL 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: 19031466
• Report Number: 9611018-2024-00017
• Device Sequence Number: 17918302
• Product Code: GCX
• UDI-Device Identifier: 10884521061026
• UDI-Public: 10884521061026
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/28/2024

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: 8888571562
• Device Catalogue Number: 8888571562
• Device Lot Number: 23I086FHX
• 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: 04/02/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 05/28/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown