This retrospective mdr is filed as a correction to an audit conducted december 2016 by a former fda investigator (consultant).We observed the package seal was compromised - the upper and lower tabs were pulled back more than normal.The cause is unknown, and might have happened due to handling at the customer or at our facility (b)(4).We subjected the returned syringe to a dye penetration test and the seal failed.This pouch was producted on a multivac form-fill-seal machine, and this particular sample was from cavity #20.Production inspection includes dye penetration, peel strength, and seal quality (visual).A review of the device history record showed acceptable performance results throughout the production for this lot for these three (3) inspections - i.E., all inspection samples met acceptance criteria.The customer returned their shipment of (b)(4) syringes.We subjected the syringes from the same intermediate carton as the alleged sample to dye penetration testing, which included syringes in pouches from cavity #20.All samples passed.We evaluated the remaining (b)(4) syringes.All products, other than the alleged product, met specifications.Zero defective seals were observed from this further evaluation.Sixty (b)(4) retain samples from lot kh04249 were evaluated, and all seals met specification.We reviewed the historical customer complaint data for the same product code (2s0706) for the year 2015 and did not find any similar package seal complaints.A further review of corrective actions taken since the manufacture of this lot of products (nov-2105) revealed that an increase in the top and bottom film used to form the package was made and validated in march-2016.No cause has been found for the reported problem and improvements have since been made in the packaging with no additional complaints of this type.
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