This retrospective mdr is filed as a correction to an audit conducted 06-jun-2017 by a former (b)(4) investigator (consultant).We observed the syringe was dirty with a surface grease-like substance that was confined to the end of the barrel of the syringe, but no loose particulate matter.Production final inspection includes a visual check of all product.A review of the device history record showed that samples met in process and final inspection acceptance criteria.Sixty (60) retain samples from lot kh04306 were evaluated, and zero defected syringes were observed.We reviewed the historical customer complaint data and cars for the same product code (2s0706) for the year 2015 and did not find any similar dirty syringe complaints.Customer reported 106 syringes, but further investigation by the customer revealed that the true number of rejected syringes was actually three (3).The original reported number was determined to be inadequate training of the customer's personal on specifications.It was determined that the syringe was received from the supplier as dirty.The supplier was notified and no conclusive root cause had been received at the processing time of this complaint.
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