Date of event: unknown.The date received by manufacturer has been used.Investigation summary: five photos and twelve heavily manipulated 1ml luer lock syringes (p/n 309648) that had undergone a secondary manufacturing process were received.Each sample appeared to have a translucent film of foreign matter on the barrel in the fluid path between the zero and 0.1ml grad lines.The film aligned with where the stopper would sit in the syringe and did not extend past where the second rib of the stopper would fall.The film appeared to be dried silicone.Additionally, three syringes appeared to have missing graduation markings and print throughout the barrels.It is unclear whether the customer manipulation of the samples or the printing process contributed to the missing print observed.Unmanipulated samples are required for a more thorough evaluation.Please note that silicone is an inert, non-toxic medical substance used as a lubricant for disposable hypodermic products.It is an integral part of the syringe, enabling it to perform as required in various clinical applications and does not present a safety or efficacy issue nor does it impact product function.The silicone application process is designed to provide an even distribution of silicone on the interior of the syringe barrel.Silicone has been in use in this application for over 20 years.No reports are known of adverse clinical effects associated with these products and unintentional delivery of silicone fluid lubricant.Please see attached silicone quantity guideline for additional information.It is unclear if the storage conditions of the product once handled by the customer could have contributed to the silicone drying as intended use is immediate.Additionally, the missing print defect observed could not be confirmed to have originated at the manufacturing plant since the product appears to have undergone a secondary manufacturing process.Since no root cause could be established, corrective actions are not necessary.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Therefore, given the above information corrective actions are not required for either defect present.
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It was reported that the bd 1ml luer-lok¿ syringe experienced scale marking issues.The following information was provided by the initial reporter: the customer has been using this syringe since 2005, using the same process.The customer advised ¿many 10's of thousands have been filled without seeing any problem of cloudiness¿.This was not noticed by the technician before filling.The second batch filled immediately after into identical syringes from a different lot did not have this ring.After filling the technician checked some remaining syringes of 1st, lot 9033665 , and saw that the empty syringes had this cloudy ring in differing degrees.The technician re-examined some of the filled syringes and noticed that several now had small white particles in the solution.Other lot produced no problem under the same conditions and using the same process.These syringes are being filled with an anti vegf solution.All the syringes were re-packed and eto sterilized according to standard protocol, so that there should be no difference between the two batches filled by the same operator.The batch of the anti-vegf drug was the same for both filled batches.
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