Root cause: the root cause was unable to be determined.A potential root cause of improper skin preparation has been identified.The instructions for use packaged with the product include a step to prep the skin by removing body oils and hair prior to probe cover application.Corrective action: due to the root cause determination, a corrective action has not been taken.Investigation summary an internal complaint ((b)(4)) was received for a neonatal probe cover (finished good hnicu-03, lot 50305961) that failed to adhere to the skin, resulting in unstable temperature readings.One sample was returned december 17, 2019, for evaluation.The sample was reviewed for visual and adhesive qualities.No discrepancies were identified.The cover was placed in different areas of the hand and arm.Each time the cover was removed and replaced; the device properly adhered to the skin.Quality records for the reported lot were reviewed for discrepancies that may have contributed to the reported event.No discrepancies were identified.Certificates of analysis for the raw materials also were reviewed and all were found to be within specification.The instructions for use packaged with the product include a step for skin preparation prior to applying the probe cover.The ifu also includes direction that, after applying the probe cover to the skin several times, it may be necessary to replace with a new probe cover.From 2017 to present, deroyal has sold (b)(4) cases of the product.There have been no like complaints during this same time period.The investigation is complete at this time.If new and critical information is received, this report will be updated.
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