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

Model Number	8884713308
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	09/30/2022
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 hospital used chest bottle with obvious creases in the drainage hose of the chest bottle, causes the drainage to be unsmooth, causing the patient¿s blood oxygen to drop rapidly and still under treatment at the hospital.Several attempts to gather information from the customer were made.To date, no response has been received.If additional pertinent information becomes available, the report will be updated.
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.A physical sample was not received for the investigation.However, a picture was provided for the analysis.Upon reviewing the picture, kink was observed and has been covered by a white tape, this tape is not placed on the tube at the manufacturing site.From the review of the picture provided, the reported condition is confirmed.The probable root cause of the reported issue could be due to the tube was wrapped too tightly causing the kink.As per standard work instruction, coil the patient drainage tube in a counterclockwise circle, ensuring no kinks in the tube, standardize the method of coiling and securing the tube to prevent the tube from kinking as a kinked tube may prevent the unit from functioning.A quality alert was issued to the manufactured line to make them aware of the reported issue.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: 15615102
• Report Number: 9611018-2022-00565
• Device Sequence Number: 17632633
• 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): 11/04/2022

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: 21K170FHX
• 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: 09/30/2022
• Supplement Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 11/04/2022
• 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