Other, other text: this remediation mdr was generated under protocol b10010116, as a result of warning letter cms#(b)(4).Additional information h6, h10 no problem or issues were identified during the device history record review.Visual inspection showed some signs of damage - scratches on the cuff which may correspond to use of the product, crumpled tubing from forceps usage, broken pressure gauge without coverslip for sample (probably caused by improper use).During functional testing, the sample was inflated to 300mm hg and the c-fusor kept the pressure for 2 minutes.Both samples stayed inflated, no leaking from the bag was observed.Based on the first investigational results, the reported issues could not be confirmed.As per the customer a second evaluation was performed.Products were inflated to 300mm hg and hung up for observation.After about thirty minutes, the pressure began to drop slightly for sample.After two hours, a pressure drop of about 50 mm hg was observed.No pressure drop was observed for the second sample.Another testing of the first sample was performed.To identify the place of leakage, the inflated sample was put in the water.Leakage was observed between luer lock male and stopcock 4-way white.These two parts are joined manually by tightening.However, even after proper tightening, the leakage was still observed.Based on the investigation results we confirmed reported issue for one of the samples.No similar customer complaints were identified.We consider this issue as an isolated incident, probably caused by material fatigue.No action taken.
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