H.6.Investigation: a device history record review was completed for provided material number 306574 and lot number 1187703.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defects and all quality tests were found to be within specification.To aid in the investigation of this issue, picture samples were returned for evaluation by our quality engineer team.Through examination of the pictures, one syringe was observed with a wrinkled label, another syringe had a piece of broken barrel within the unit packaging, and another unit package was observed torn.The barrel piece found inside of the package was most likely a result of a jam in the syringe feeder; however, based on the pictures alone, it cannot be confirmed if the broken piece is from the syringe it is packaged with.The wrinkled label originated at the label dispenser due to an excess of glue.This is a label material defect and we are currently working with the supplier on this issue.The production plant has increased the frequency of the label dispenser cleaning in order to avoid this issue.In the case of severely sticky labels, the operators clean the dispenser every fifteen minutes.If the packaging length is cut too short, the tension applied at the areas of the tip carp or plunger may lead to film breakage.This type of defect may result if the unit packaging station is not well adjusted and the film is not centered.H3 other text : see h.10.
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