Root cause: a root cause could not be determined.The manufacturing process has not changed.Product was manufactured according to specification.According to the certificate of analysis received from the hydrogel supplier, the raw material was manufactured according to specification.A possible root cause could be improper preparation of skin as detailed in the instructions for use, which direct the end user to remove body oils and hair prior to placement of a new probe cover.Corrective action: due to the investigation and root cause determination, a corrective action has not been taken.Investigation summary: an internal complaint (call (b)(4)) was received for a hydrogel probe cover (hnicu-00, lot 50238421) that was peeling off the patient's skin during use.This was causing temperature misreading.No injury was reported, however, the end user indicated staff intervention was necessary because the isolette temperature needed to be adjusted due to the inaccurate readings.Two samples from the reported lot number were returned 9/3/2019 for evaluation.One of the samples had been removed from the pouch and liner and stuck to the pouch.The product could not be released correctly from the pouch and therefore could not be evaluated for the reported issue.The second sample was evaluated and determined to be sticky.It stuck to skin even after being removed and reapplied.The product is designed to have less aggressive adhesive properties due to its intended use on neonatal patient's.The work order for the reported lot was reviewed for discrepancies that may have contributed to the event.No discrepancies were identified.Lot mapping was used to identify the hydrogel raw material lot used to manufacture the finished good.It was confirmed that a certificate of analysis was received for this lot (136150 from lec tec gel), and confirmed that the hydrogel raw material was manufactured according to specification.There have been no changes to the raw materials or manufacturing process.From 2017 to present, no similar complaints have been received for hnicu-00.During this period, deroyal has sold 2,334 cases of the finished good.Deroyal will continue to monitor post market feedback, and will recognize in the future if the issue recurs.The investigation is complete at this time.If new, and critical information is received, this report will be updated.
|
The temperature probe cover is peeling off the patient's skin, causing misreading.It was placed on the neonate's stomach.No injury was reported, but staff intervention was necessary.The misreading required the staff to adjust the isolette temperature, which changed due to the false temperature reading.The reading falsely indicated the infant's temperature was decreasing.
|