The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
|
A device history record review could not be performed because the lot and serial numbers were not received with the complaint.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 customs policies.As a result, photos were taken of the sample that was received at our decontamination lab and 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.A root cause analysis indicated that this condition occurred as a result of a workmanship issue.As part of continuous improvements, a corrective action has been opened to address this condition.A new solvent dispenser was implemented for a better handling of the solvent during the assembly process of the y-port.This complaint will be used for tracking and trending purposes.
|