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

Model Number 8888570549

Device Problem Material Deformation (2976)

Patient Problem Pulmonary Emphysema (1832)

Event Type  Injury  

Event 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.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

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
• Type of Device: 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
• MDR Text Key: 334614442
• Report Number: 9611018-2024-00006
• Device Sequence Number: 1
• Product Code: JOL
• Combination Product (y/n): N
• Reporter Country Code: GR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• 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
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1