Batch record review: the batch record review supports that there were no discrepancies related to the issue reported.This batch was manufactured following the applicable procedures, all machine and testing parameters were in accordance with the applicable procedures and specifications, the testing results were found satisfactory and no nonconformance related to the malfunction code in analysis was noted.The line clearance was executed per dr-sop-0094 ¿procedimiento de despeje de línea y chequeo de seguridad (line clearance procedure and safety check)¿, the results were documented, and no issues were identified during the manufacturing process.The materials comply with the correct parameters, procedure instruction (pi), ds, mt, tm and the results are satisfactory.Photograph, video and/or physical sample evaluation: no photographs associated with this case were received and no unused return sample was expected.Executive summary of the non-conformance (nc): based on the results of the preliminary investigation, the batch record reviews were performed, and no discrepancies were found.A revision of the improvements made to the process was performed, and actions have been implemented for this type of incidents.In addition, an upgrade of the guard robot arm, disc collar and pouch assembly process was performed.These improvements performed to the guard machine, contribute to the reduction of possible defects related to off center.The last batch received was manufactured prior to the implementation of these improvements.Furthermore, a complaints search conducted shows that no adverse trend was identified from january 2019 to august 2020 for this failure mode.This failure mode will keep monitoring for track and trending.For this reason, no additional investigation is needed.The investigation associated with related event has been approved and is complete.No additional action is required, and this complaint will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092 manufacturing site: 9618003.
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