The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
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The lot number was provided and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The equipment used was in proper functioning condition during the manufacturing, filling, and packaging of this lot.One unopened syringe was returned for the evaluation.The syringe was opened, and the air was pushed outside the syringe before letting go of the plunger.The plunger then receded back into the barrel letting air inside.Therefore, the issue reported by the customer is observed.The investigation demonstrated that, no issues were recorded throughout the manufacturing and control processes.The manufacturing records, including autoclave documents, were reviewed and no possible related event occurred during the overall process for this lot.A review was performed specifically for the plunger and syringe issues in the manufacturing records and no issues were found.Also, each lot is released based on an aql sampling.As per the final quality inspection report of this lot, all specification criteria were conforming.The product was in conformance to the specifications and was released for distribution, meeting all the established quality assurance acceptance levels.The returned sample was sent to the supplier of the syringes for the analysis.The examination showed a slight bulge on the syringe just above the 10 ml mark of the label.A bulge is a slight deformation of the barrel, a variation of the diameter on the barrel length.The negative push back of the plunger into the syringe upon opening is most likely due to the bulge in the syringe near the 10 ml mark.The rubber tip is designed with a larger outside diameter than the syringe barrel internal diameter.This design is intentional and prevents any leakage during use while providing a good seal to maintain sterility of the finished product.This design causes the rubber tip to put pressure on the barrel walls.When the syringe goes through the autoclave process, heat is created which likely causes the syringe barrel wall to form over the rubber tip creating this bulge above the 10ml mark where the rubber tip resides.Depending on the actual dimensions of the rubber tip, barrel internal diameter and autoclave processing, the extent of bulge may vary.The bulge is found to be inherent to the sterilization process and therefore, it is not considered as an issue.The root cause of the reported incident is due to the supplier¿s process.A formal investigation is not deemed necessary at this time.
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