The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 08-feb-2023.H6: investigation summary an unopened sample was returned for investigation.Through visual inspection, the customer complaint was confirmed.The female luer was discolored and darker than the rest of the set.A device history record review for model 30204e lot number 22109399 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The manufacturing plant was notified of this defect, and an investigation was performed where possible root causes were determined.A potential root cause for this defect was determined as an issue at the supplier.The supplier was notified of this defect.An investigation could not be performed as the set had already been sterilized.Another potential root cause of this discoloration is related to the sterilization procedure which iv sets undergo to help ensure product sterility.These iv sets are sterilized by irradiation, which uses electron beam or gamma rays to produce a sterile and safe iv product per iso 11137-1 and iso 11137-2, international standards for the sterilization of health care products.These standards are recognized consensus standards by the fda, which are adhered to by bd to specify the requirements for the development, validation, and routine control of a radiation sterilization process.The irradiation process is known to modify polymers which causes some discoloring, depending on the applied radiation level (dose) and material choices.The degree or intensity of discoloration can also change over time, as it approaches shelf life, and under certain storage conditions such as high temperatures.Nonetheless, this type of discoloration is strictly cosmetic and does not affect the safety and functionality of the device as tested and sterilized.
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