The complaint was received and forwarded on to the manufacturing facility for investigation.A review of the manufacturing device history record for lot number 17g03 provided by the customer was completed.The product was manufactured (b)(6) 2017.No non-conformance with regard to ¿cracked lids¿ or ¿imploded lids¿ were documented during the manufacturing of this batch.This investigation determined that all products were manufactured, inspected, and released in accordance to our established specifications for quality and efficacy.No sample was provided by the customer thus an evaluation of the complaint device for deficiency of construction could not be performed.Note: if the event sample is received at a later date and provides a different conclusion, an addendum report will be written.Without the actual event sample involved in the customer incident and duplication of the non-conformance, no specific assignable cause can be determined regarding the reported incident.Without a specific assignable cause, no specific corrective actions can be completed; however, we will continue to monitor concerns such as these for possible future actions.Key production and quality personnel have been made aware of this reported incident through the investigation process.Trending of past product quality reports indicate that this is the 1st reported incident regarding imploded flex lid in the past calendar year for this particular part number.No further action is planned at this time.
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