MAUDE Adverse Event Report: CARDINAL HEALTH, INC. ARGYLE; TROCAR

Model Number	8888561068
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that during the end of (b)(6) 2024, the thoracic catheter was kinked at the point of entrance, or was kinked intrathoracic, and was not functional.The procedure performed was a thoracic procedure.The patient is safe, but hospitalization was prolonged.Additional information was received from the customer and stated that at the second postoperative day, the chest tube was seriously kinked at the point of entrance.Per customer, the patient was already hospitalized, and the hospitalization was prolonged.
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) unopened, unused representative sample was returned for evaluation.Upon visual and dimensional inspection, the reported issue was not confirmed, and the root cause of the reported event cannot be identified to be related to the manufacturing process.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: ARGYLE
• Common Device Name: TROCAR
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; sragh industrial estate, co, t; offaly ; EI
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 19955246
• Report Number: 1423537-2024-00106
• Device Sequence Number: 21057141
• Product Code: DRC
• UDI-Device Identifier: 10884521029309
• UDI-Public: (01)10884521029309(17)241112(10)19K137FHX
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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?: Yes
• Device Model Number: 8888561068
• Device Catalogue Number: 8888561068
• Device Lot Number: 19K137FHX
• 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: 07/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 09/25/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown