A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.No physical sample has been returned for evaluation, therefore, the condition of the product could not be verified.This record was triaged during the pak accountability meeting and it was concluded that this file will be closed via complaints.A review of the reported pak's bill of materials (bom) shows that each unit should include (1pa) non-latex gloves.A review of the deviation history report shows this finished goods lot had a temporary deviation applied for the unavailable component (non-latex) to be substituted with available alternative (latex).A review of the sap batch where-used list shows all (latex) were built into this finished goods lot.The root cause for the reported event is due to an approved temporary deviation.The deviation was to substitute unavailable component (non-latex) for available alternative (latex).A review of the manufacturing records confirms there was no problem with the build of the pack the pack was built correctly with the correct glove type.However, the root cause for the non-latex to latex substitution is due to a system indicator not programmed within the sap deviation table to prevent deviating from non-latex to latex.Company has taken action to determine root cause and implement appropriate corrective based on observed trend for complaints of a similar nature.To address root causes, the following action was taken: impacted lots were placed on hold both internally and the order parts lists revised to use non-latex gloves as the substitution.Impacted lots shipped to the distribution centers (dc) were advised to be placed on hold.Furthermore, pak planning aligned with center of excellence (sap it) to create an enhancement in sap deviation table to prevent deviating from a non-latex component to a latex component.This will prevent customers from receiving latex items in their pack if the original components are non-latex.Complaints are continuously monitored to identify product and/or process areas where this type of issue is occurring.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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