Nurse assist saline flush syringes are single-use devices.The company does not know if the products were reprocessed or reused on patients.No used syringes were returned to the manufacturer.Manufacturer tested retained samples for bioburden, and there was no presence of b.Cepacia in those samples.On 10-03-2016, the (b)(6) informed nurse assist that syringes from lot number 1607418 tested positive for b.Cepacia.(b)(6) sent the company unused syringes from one of the affected facilities, and testing on those products is on-going.Manufacturer is also aware that (b)(6) have issued notices regarding cases of b.Cepacia infection that may be associated with nurse assist saline flush syringes, and investigations are still on-going.Our investigation is ongoing.This form was originally submitted via (b)(6) delivery on 10/28/2016.The form was returned and nurse assist was informed that it must be submitted online.This is the first emdr submission for nurse assist.Final submission is made 12/01/2016 as soon as the registration and test submission process was completed.Additional submissions will follow as needed.Nurse assist initiated a voluntary recall for all lots of saline flush syringes.The removal was initiated on (b)(6) 2016.Device not returned to manufacturer.
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On 09-28-2016, (b)(4) (a distributor) verbally reported to nurse assist that, between (b)(6) 2016, (b)(4) patients had experienced infections that were potentially related to nurse assist's saline flush syringes.The facilities began using p/n 1210-bp on (b)(6) 2016.(b)(4) noted that there was no direct evidence that the syringes are a root cause, but that they are common to the patients with the infections.Despite efforts, manufacturer has been unable to obtain further information about the reported events from (b)(4).Accordingly, the 3500a form for each of the (b)(4) reported infections will contain the same information.
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