MAUDE Adverse Event Report: CARDINAL HEALTH STR THOR CATH 20FR; CATHETER AND TIP, SUCTION

Model Number	8888570523
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2023
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 when performing pleural drainage for a pneumothorax in a patient, it was impossible to remove the trocar used to place the drain.Indeed, the diameter of the drain is larger at the distal end, which made it impossible to remove the trocar.Consequences were listed as endangerment of the patient, unstable state and hypoxemic patient.
Additional Manufacturer Narrative
A decontaminated sample was received at the plant 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 sample, the defect was not confirmed; there were no defects noted.
Additional Manufacturer Narrative
Updated section b5: describe event or problem.Updated section h6: evaluation codes - health effect - clinical code and impact code.
Event or Problem Description
Per additional information received on 31mar2023, the customer stated that the patient had cardiac arrest followed by a pneumothorax.As a result of the pneumothorax, the doctor placed a reusable metal trocar from another manufacturer.The cardinal health thoracic catheter was then placed into the reusable metal trocar; however, it remained stuck and would not release from the cardinal health thoracic catheter.As a result, the doctor had to remove and replace the cardinal health thoracic catheter along with a larger diameter reusable metal trocar, from another manufacturer.There was no patient injury to date.

• Brand Name: STR THOR CATH 20FR
• 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 ; EI
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 16668203
• Report Number: 9611018-2023-00581
• Device Sequence Number: 5933928
• Product Code: JOL
• UDI-Device Identifier: 10884521050839
• UDI-Public: 10884521050839
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 05/19/2023

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
• Device Model Number: 8888570523
• Device Catalogue Number: 8888570523
• Device Lot Number: 22E095FHX
• 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: 03/13/2023
• Supplement Date Received by Manufacturer: 03/13/2023; 03/13/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 04/21/2023; 05/19/2023
• 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