This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.Two photos were included for evaluation; the photos showed the complaint sample.A returned sample was received in use conditions without the original packaging.Visual inspection: the returned sample was visually inspected at 12in to 16in and normal conditions of illumination.Per visual inspection, damage was detected in the cuff of the tracheal tube.Leak test: the leak test was performed, the returned sample was inflated with a syringe and submerged under water to detect any leakage, the sample failed the test.The complaint was confirmed.Based on the analysis performed on the sample and the photos provided, the leakage failure mode was confirmed.However, according to the customer's report, the product was found damaged during use, during pre-testing no leakage was reported in the cuff as described in the instructions for use (ifu), and it was up to 12 hours after use that the leakage occurred in the product, the root cause could be due to improper use of the product.Also, capa was opened on january 5th, 2022, to address root cause investigation for leakage issues.
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