The customer reported that the inside piece that screws onto the syringe came off and she's having trouble keeping it on while feeding her husband.Per additional information received, the customer had to go to the doctor due to the piece coming off, that she was using tape to hold.The doctor changed the device immediately.
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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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.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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