Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: no product or photo was returned by the customer.The customer complaint of separation could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 2420-0500 because a lot number was not provided by the customer.Due to no sample received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: due to no sample received, an investigation could not be performed and a root cause could not be determined.
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It was reported that the gem v/nv 20dp ckv 2ss 117-in 20pk experienced damage, component separation, and leakage.The following information was provided by the initial reporter: per (b)(6) law compliance, (b)(6) website has recently uploaded reports that they have received since (b)(6) 2020.Unfortunately we do not have any additional information nor customer contact information.These events were pulled from (b)(6) medical device incidents database.Chemical exposure, defective component, loss of or failure to bond, fluid leak.
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