One hundred and sixteen samples of 5ml luer-lok syringes (p/n - 309646) were received and evaluated.Eight individual bags each containing a bag of sealed packages from a different batch; consisting of 75 samples from batch 0175566, 24 samples from batch 1181080, 4 samples from 7324720, 4 samples from batch 8267569, 3 samples from batch 9344915, 3 samples from batch 7194570, 2 samples from batch 7086527, and 1 sample from batch 6026822.All samples were found to have no oil or excessive silicone defects and acceptable.Ftir analysis testing was performed and confirmed the substance to be silicone used in the manufacturing process.The condition observed is acceptable per product specification.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.Silicone has been in use in this application for over 20 years, with estimated distribution well in excess of 25 billion units.No reports are known of adverse clinical effects associated with these products and unintentional delivery of silicone fluid lubricant.The reported defect was not identified in the samples received.Therefore, no corrective action is required at this time.Batches 1181080, 0175566, 9344915 are considered in compliance with our product specification requirements.The syringes from batches, 8267569, 7324720, 7194570, 7086527, and 6026822 have been expired since 09/30/23, 10/31/22.06/30/22, 03/31/22, and 01/31/21 respectively.Bd does not make claims of the efficacy of expired product.A device history record review is not required due to the complaint being for the design of the product and not a true defect.
|