We received the incriminated sample which allowed us to retrieve the lot number.After decontamination, we see that the balloon was burst without missing part.We searched for other complaints and we didn't find any other complaints regarding the lot number 9177710.This product was made by our subcontractor which was informed about this issue.On january, we received documentary's investigation from our subcontractor, the probably root cause about this issue was raw material's balloon.Checking the quality databases revealed one non-conformity in relation to the described defect and a corrective and preventive action are ongoing: - nc (b)(4): "pb ballons (bulles + agglutinés)" opened in 16 january 2023.For this nc, the used of clumped balloons should be responsible of some weakness on the balloon and being responsible of bursting.- capa-000152: "balloon bursting trending for folysil and silicone prostatic catheters".The trending for balloon bursting is specifically monitored.A similar case study was done based on same item number (b)(4), same defect "balloon burst", over last four year, 6 similar case were found.
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