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.
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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.
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