MAUDE Adverse Event Report: CARDINAL HEALTH ENTRFLX 8FR 36INW STYLTY SITE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884720825E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
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 an 8fr weighted tube had been inserted in a patient from march 8-march 31st and was leaking from the joint below the moat.Additional information received from the customer on (b)(6) 2023 stated the leak was at the seam below the y-port before the tapering.The device was removed and replaced requiring an x-ray for the new tube placement one week earlier than if the tube remained intact.There was no injury to the patient during the incident.
Additional Manufacturer Narrative
A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.One sample was received for evaluation.The sample was visually inspected and it was noticed that the device arrived damaged; broken at the bottom of the port and the tube in 2 parts.A leak test was carried out and there was no leak in the assembly of the port as mentioned in the complaint.Instead, the leak that was confirmed was caused by a cut or repair which did not originate during manufacturing.A gemba was carried out in the manufacturing process.The current process and controls were found to be followed correctly, including subassemblies, finished product assembly, packaging, and product inspections.No conditions were found that could trigger the condition therefore an exact root cause was not able to be determined.No corrective actions are required at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: ENTRFLX 8FR 36INW STYLTY SITE
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 16708539
• Report Number: 9612030-2023-03670
• Device Sequence Number: 5821451
• Product Code: KNT
• UDI-Device Identifier: 10884521582941
• UDI-Public: 10884521582941
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/01/2023

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: 8884720825E
• Device Catalogue Number: 8884720825E
• 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: 04/03/2023
• Supplement Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown