A device history record review could not be performed because the serial number was not received with the complaint.However, as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.One physical sample was received at our decontamination lab.However, at this time the used sample cannot be forwarded to the manufacturing site for physical evaluation due to current covid 19 customs policies.As a result, the photo the customer provided along with photos taken by our decontamination lab of the received sample were shared with the manufacturing site to aid the investigation.Upon a visual evaluation of the photos, the reported issue was confirmed; a detached component was observed.The root cause could not be determined based on the photo evaluation alone.However, if additional information becomes available or the sample is received by the manufacturing site, the investigation will be updated accordingly.As part of continuous improvements, a corrective action has been opened to address detached components.A new solvent dispenser was implemented for a better handling of the solvent during the assembly process of the y-port.
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