MAUDE Adverse Event Report: CARDINAL HEALTH, INC. ARGYLE; CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY

Model Number	8888573048
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
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 while trying to place the right-angled chest tube in a coronary artery bypass graft aortic valve replacement, the tube came apart.They typically tug on it to pull it through the skin, but this was not where they tug.There was no patient harm reported.
Additional Manufacturer Narrative
The device history record (dhr) for lot 230090053 was reviewed and no anomalies related to the reported issue were observed.A physical sample was not received for the investigation; however, a picture was provided for evaluation and the reported condition was observed.Because a physical sample was not returned, a certain root cause could not be determined.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: CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 19995241
• Report Number: 1423537-2024-00116
• Device Sequence Number: 7001419
• Product Code: GBS
• UDI-Device Identifier: 10884521025509
• UDI-Public: (01)10884521025509(17)271231(10)230090053
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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: 8888573048
• Device Catalogue Number: 8888573048
• Device Lot Number: 230090053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 11/07/2024
• 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