Premarket (510k) number is unknown.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Suction line was found detached from suction connector.Based on the information provided in the complaint description and the sample provided, it is most likely that the unit was damaged once it left manufacturing site.Since manufacturing performs a 100 percent inspection of the device for damage in different parts of the process and quality performs an inspection on a representative sample of each lot, also the tube has remaining dry solvent applied.All mitigations on placed were verified and it was confirmed has been executing according, therefore no corrective actions could be implemented, it will be continue monitoring this failure condition in this product for threshold or escalation.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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