Based on the investigation, teleflex feels the root cause is substantial light exposure of the devices in the heal care facilities which resulted in degradation and embrittlement of the dilator polymer.This failure mode is not within teleflex¿s control.Product met the product specifications at time of manufacture.Since teleflex was not responsible for design validation, accelerated aging and storage/environmental evaluation of the device post sterilization, teleflex is unable to confirm the complaints.Current dilator inventory was sampled and checked for flexibility and brittleness through completion of a bend test.All product inventory passed inspection and was released.Although complaint is not confirmed, teleflex (b)(4) will implement a preventive action ecn in which the minimum elongation and tensile break will be increased.This will provide additional initial polymer material strength on extruded dilator tubing material and would offer surplus tubing flexibility.As such, this could reduce or eliminate early product failures due to environmental storage conditions, specifically light exposure.
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This supplemental report is being submitted to provide additional information regarding dhr review performed.Please see the updates in sections: g4, g7, h2, h6 and h10.The oem performed a review of the device history record (dhr) and found no anomaly with the event-related items with this lot.
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