The customer reported that they have seen an increase in nec (necrotizing enterocolitis) in the nicu.They have been exploring multiple avenues to assess what could be contributing to this.After working with infection prevention and obtaining cultures on multiple patients, they have determined that the findings are concerning with the possibility of bacteria being introduced to their babies through the enteral feeding tubes via the moat.They have tried multiple routes to clean the feeding tubes - the two different bristle brushes and the toothbrush (see attachment), did not seem to clean the 'moat' of the tubes thoroughly.The suggestion on the attached cleaning practices was to clean the moat once a shift.So, they came up with their own practice to flush the tubes with 1cc sterile water and then rinse the moat with 2cc of sterile water after each feed and tap the moat onto a sterile gauze.The cultures were obtained after this cleaning practice was initiated and they still have these results after culture.Per additional information received, the tubes that were tested had been used.They did not visibly see signs of the bacteria or any foreign substance in the moat of the tube.The customer was unable to provide any further information.
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Samples were not received for the investigation.A device history record review could not be performed because a lot number was not received with the complaint.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine the root cause, therefore a corrective action is not applicable at this time.If a sample is received at a later date, this complaint will be reopened for further investigation.This complaint will be used for tracking and trending purposes.
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