Other, other text: h6: event problem and evaluation codes: updated.H3: device evaluated by manufacturer: updated.H10: device evaluation: the sample was returned for investigation.The sample was received without its original packaging, decontaminated and inside in a plastic bag.The sample was visually inspected under normal conditions of illumination to detect conditions that could cause functional issues.No obstructions, damaged or broken, or other defects were detected in none of the joins of the product.Leak testing on the sample received was performed using hydrostatic vessel as procedure.A leak was detected at the joint of the tube and the filter, thus the failure mode reported was confirmed.Per the investigation, the occurrence of the fault condition could be caused by an incorrect solvent dispensing setting and insufficient solvent in solvent container.The cause was traced to manufacturing.For corrective action, production personnel were notified by quality engineer as an awareness for the failure mode.No lot number was provided; therefore, device history record review could not be completed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4)., corrected data: correction: no lot/serial number was provided, therefore the product manufacture or expiration date was unknown.
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