Date of event: unknown.The date received by manufacturer has been used for this field.Investigation: based on the investigation of the reported issue, the root cause is determined to be related to the sterilization process.The staining occurs as a result of the interaction between the paper and the moist heat sterilization process.It appears only on the outside of the packaging and does not permeate in any way onto the product.Test results have confirmed the stains do not present any risk to the use of the product and have no impact on the effectiveness, sterility, quality or safety; it is cosmetic only.In response to the increasing amount of staining presence, a corrective and preventive action plan has been initiated to address the staining associated with this particular blister top web packaging material.The corrective and preventive action plan is in the investigation process and our quality team is gathering and interpreting data at this time.Investigation activities: the brown staining present on the sf paper top web was observed and reported during the design verification activities.Test results have confirmed the staining to be cosmetic in nature.Samples were shared with customers prior to product launch and the physical appearance of the product was accepted by the customer.The staining occurs as a result of the interaction between the paper and the moist heat sterilization process.Investigation conclusions: the water mark type staining is cosmetic in nature, appears only on the outside of the packaging and does not permeate in any way onto the product.Furthermore, microbial permeability testing, cytotoxicity testing, and testing for residual solvents and volatile species has been completed on the packages displaying the brownish stain.The testing confirmed that they do not present any risk to the use of the product and have no impact on the effectiveness, sterility, quality, or safety of bd posiflush sf 10ml saline flush syringe.Corrective action: required.Capa (b)(4) has been raised following unit level discussions in september 2017.Exceptions: lot numbers manufactured prior to lot 6315951 may have associated staining complaints as a result of sterilizer component issues.This was addressed in capa (b)(4) and the associated corrective action was implemented november 2016.Lot number 6315951 was the first lot number manufactured post corrective action implementation.Lot numbers prior to lot 6315951 may generate customer complaints for staining, these complaints are not within scope of this pic and shall be addressed on an individual basis.Root cause: based on the investigation of the reported issue, the root cause is determined to be related to the sterilization process.The staining occurs as a result of the interaction between the paper and the moist heat sterilization process.
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After further evaluation, it was determined that this incident is not mdr reportable.The complaint by the customer stated that the outside of the syringe packaging contained water marks, making it impossible to ascertain sterility.However, according to our position on reporting prefilled saline flushes for sterility breach, it is only reportable if the cap is off the device, which was not the case for this incident.
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