(manufacturer narrative = t, corrected data = f) (b)(4).Product returned and evaluated.Qc investigation on 8/28/2017 result in no defect found.Mlc-3: use error caused or contributed to event based on the post market review syr-pmr-100 and review of the fda's total product life cycle (tplc) - total device problems, for possible delay in administration of insulin.Reference - capa (b)(4).Note: manufacturer contacted customer on 5/27/2017 in a follow-up call to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention or symptoms since the last call.
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I am writing to you about a dangerous situation that escaped quality control.I like your syringes much better than those available at (b)(6) , so i hope this is a problem that will never happen again.So far, in the first 60 syringes i've used in this 100-syringe box, at least three have not pulled any insulin out of the syringe.I anticipate finding one or two more before i reach the end of this box.This is scary because i give my cat two insulin shots per day and i want to be able to trust your syringes to perform as they should in the future without having to peer closely at the syringe to make sure the insulin has gone into it.The defective syringes are sunmark trueplus 31g 0.3 cc single use insulin syringes with an expiration date of 2019/08/10 and a lot number of np16155.Each of the defective syringes was in a separate bag, making it look as if someone was aware of the problem and didn't want to trash a whole batch, so they spread them out enough so that customers would be less likely to use two or three of the defective syringes in a row, risking a medical emergency.If you have more of the syringes that have not shipped yet, i hope you don't ship them out to unsuspecting customers and that you can recall the ones currently on pharmacy shelves.Thank you.We spoke to the customer and she states that the syringe was not pulling the insulin in.There was 3 syringes that were not working and she discarded 2 of them but she has the other one.There was no medical emergency for the cat.Due to not knowing if any other syringes are defective, i will replace the syringes (100) for the customer.
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