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

Model Number	8884713308
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that due to the bubbling noted in the chest drainage unit (cdu), the physician attempted to locate the source of air leak bubbling in water seal and suction control chamber with suction regular on noted while chest tube was clamped.The customer stated that a leak from patient was ruled out therefore the cdu itself must be malfunctioning.There was no injury to the patient or staff involved.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Section d4 (lot number): originally reported as 22b096fhx and should be 22b140fhx.
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.One (1) open and used sample was returned for the evaluation.Visual inspection was completed on the sample with no issues noted.Unfortunately, as the sample was used, the site could not test it, therefore the reported issue cannot be confirmed.During the manufacturing process on thoraseal 3 vessels, they are all 100% leak tested and 100% functionally tested as part of the process.Also, independent sampling is completed by quality assurance (qa) to confirm units are functioning correctly.At this time, a corrective and preventive action is not deemed necessary.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa 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: 16101764
• Report Number: 9611018-2023-00573
• Device Sequence Number: 17707882
• Product Code: KDQ
• UDI-Device Identifier: 20884521101118
• UDI-Public: 20884521101118
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/01/2023

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: 8884713308
• Device Catalogue Number: 8884713308
• Device Lot Number: 22B140FHX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2022
• Supplement Date Received by Manufacturer: 12/23/2022; 12/23/2022
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 01/19/2023; 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown