MAUDE Adverse Event Report: CARDINAL HEALTH STR THOR CATH 28FR; CATHETER AND TIP, SUCTION

Model Number	8888570549
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Pulmonary Emphysema (1832)
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that during the thoracic surgery incident, a chest tube was inserted.Unfortunately, the tube collapsed, rendering it ineffective and posed a life-threatening situation for the patient.In more detail, the customer reported that in the last two months and from their patient's outcome, they observed a possible chest drainage system disorder.During the thoracic procedure, they developed serious subcutaneous emphysema at early postoperative time.There was a normal drainage system movement without an air leak during respiration and emphysema was present.When they put suction at the system, a serious air leak was present.The patient had serious complications and prolonged hospitalization.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
A photo sample was received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Upon a visual evaluation of the photo sample, the reported issue was confirmed; the tubing was kinked.A root cause analysis indicated that this occurred due to user error.If a physical sample is received at a later date, this complaint will be reopened for further investigation.

• Brand Name: STR THOR CATH 28FR
• Common Device Name: CATHETER AND TIP, SUCTION
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; sragh industrial estate, co, t; offaly 22500 ; EI 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18646767
• Report Number: 9611018-2024-00006
• Device Sequence Number: 12526559
• Product Code: JOL
• UDI-Device Identifier: 10884521050846
• UDI-Public: 10884521050846
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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): 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 8888570549
• Device Catalogue Number: 8888570549
• Device Lot Number: 22D059FHX
• 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: 01/15/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 03/19/2024
• 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