Additional info: tab d- lot number an event regarding damage to an exeter horse collar was reported.The damage was confirmed through the return of the device.Conclusion: the reported event was reviewed by the supplier bemis.Final response was received from the supplier 27 june2018.They had reviewed their batch records, and no evidence of unusual process was found.Their stock on hand was inspected, and no defective product was found.The supplier stated that this defect had never been observed before, but they established a shortlist of the most likely causes, and attempts were made to reproduce the effect.A definitive root cause could not be determined as these attempts were unsuccessful.However, the most probable cause of the defect was defined as being a result of a vent channel being blocked during the manufacturing process.The assessment was that this was an isolated occurrence, a singular defect that would not have affected the entire batch.As part of a corrective plan, additional cleaning controls have been implemented and the visual inspection for this defect has been incorporated into the production process inspection routine.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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