Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms (b)(4).A sample was returned for evaluation; received inside of a plastic bag.The sample was visually inspected and there was damage in the circuit.Based on the visual inspection, the complaint is confirmed.During leak testing, it was noticed that the device was leaking.Additional testing was performed: such as evaluating the condition of the binders in the process and evaluating if the unit can be damaged if it is stuck.It was concluded that failure reported could not be reproduced in the manufacturing process according to the analyses.Root cause is unknown as the investigation did not reveal that the defect was caused during the manufacturing process.No corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process.Updated d3.D4 (udi), g5 are unknown.
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