MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 12FR EN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884715122E
Medical Device Problem Codes	Deflation Problem (1149); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2023
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 the 12 fr kangaroo g-tube had a broken med port and balloon.The tube was inserted on (b)(6) 2023 and it was broken on (b)(6) 2023.There was no harm reported.Additional information was received and stated that the y-port was detached from the tube.Per customer, there was no water in the balloon at the time of the change and when the tube was removed.The customer is not sure if the balloon was deflated with a pin hole or leak.Unfortunately, they did not look at it that closely to investigate if it was ruptured or leaking.There were no fragmented pieces left inside the patient involved.There was no harm reported.
Additional Manufacturer Narrative
Since a lot number was not provided, the device history record could not be performed.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.One gastro feed tube with y-port was received for the analysis.Upon visual inspection, a disassembly between the "y-port body enteral" and "enfit body connector can be observed.A gemba walk was carried out in the manufacturing area with the multifunctional team.The possible root cause of the disassembly could be due to the missing of solvent in the assembly, between the "y-port body enteral" and "enfit body connector¿.As an action plan, a new dispenser of solvent was validated without change the manufacturing process.Upon visual inspection of the returned sample, the reported issue of deflated balloon can also be observed.Since the device is provided by an external supplier, a corrective action (capa) has been generated to the supplier to determine the root cause and corrective and preventive actions for the deflated balloon, if required.This complaint will be used for tracing and trending purposes.

• Brand Name: GSTRO FEED TBE W/Y PRT 12FR EN
• 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: 16526384
• Report Number: 9612030-2023-03635
• Device Sequence Number: 2645206
• Product Code: KNT
• UDI-Device Identifier: 10884521661622
• UDI-Public: 10884521661622
• 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): 06/09/2023

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: 8884715122E
• Device Catalogue Number: 8884715122E
• 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: 03/08/2023
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 06/14/2023
• 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