(b)(4).The following information was requested, but unavailable: was there any adverse patient outcome? if yes, please explain.Was there any medical or surgical intervention performed? update to patient current condition.Investigation summary: it was received for analysis an opened folder with a parked needle suture piece of product code u7003.During the visual inspection of the sample, it was observed in the area of stamping and bonding with crack barrel and marks on the needle body.In addition, excess of epoxy was noted inside of the needle barrel and also the end of the suture was observe to be cut that appears to be due to the use of a surgical instrument.The manufacturing records couldn't be reviewed as the batch number is unknown.Due to the sample condition, the assignable cause of excess of epoxy, suggests an improper handling of the sample due to the needle barrel was cracked.
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It was reported that a patient underwent a glaucoma procedure on an unknown date in (b)(6) 2019 and suture was used.The suture left a larger hole than normal in the tissue.Upon closer inspection, it was seen that the needle end was not properly closed around the suture and excess glue in the back of the needle.As a complication, there was an increased leakage after the needle stick but the patient was not injured.The procedure was not delayed and was completed successfully.There were no patient consequences reported.
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