MAUDE Adverse Event Report: CARDINAL HEALTH THORA SEAL 3; BOTTLE, COLLECTION, VACUUM

Model Number	8884713308
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	Unspecified Blood or Lymphatic problem (4434)
Date of Event	11/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported due to gas leakage, cause patient¿s safety seriously.Additional information received stated the device was leaking air.They were unsure where the leak was coming from.This was noticed after using and the leak effected the suction.The air couldn't be drained smoothly causing the patient's blood oxygen to decrease, but the healthcare provider noticed and corrected the issue.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.No sample was available for evaluation.Without a sample, we are unable to perform a thorough follow up investigation.The reported condition could not be confirmed.If a sample should be returned at a later date, this complaint will be reopened, and the investigation updated to reflect our findings.Photos provided have been reviewed by the team.No issue can be seen on the photos.The root cause of the reported event cannot be identified.The associated data will be fed into the risk management quarterly report.This complaint will be used for tracking and trending purposes.

• Brand Name: THORA SEAL 3
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• 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: 18464273
• Report Number: 9611018-2024-00001
• Device Sequence Number: 15251901
• Product Code: KDQ
• UDI-Device Identifier: 20884521101118
• UDI-Public: 20884521101118
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 01/22/2024

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: 8884713308
• Device Catalogue Number: 8884713308
• Device Lot Number: 23A141FHX
• 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: Not provided
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 01/22/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown