It was reported during use of the bd discardit¿ ii syringe ¿during drug or blood aspiration there is significant leakage to the space between barrel and plunger, no precise syringe calibration.Health care worker was exposed to blood however personal protective equipment worn, no direct contact with skin.¿ there was no report of injury or medical intervention.
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Investigation summary: sample evaluation n/a.Bhr review we have reviewed our production and inspection records and have established that all production and quality processes were carried out normally.Neither qa nor ncmr's.Syringes were packed in machine nº2024 (september 17 - 19th, 2017).Syringes were assembled in machine, nº4255, nº4254, nº4237, nº4236, and nº4220, in lot #7251002 (september 11 - 18th, 2017) and in lot #7258082 (september 18 - 25th, 2017).Research has found no problems, defects or qn related to the reported issue.We have also reviewed the barrels lots #7258040, #7251464, #7244048, and #7237223 and no problems, defects or qn related to the reported issue were found.We have also reviewed the plunger lots #7258041, #7251467, and #7244049 and no problems, defects or qn related to the reported issue were found.Investigation conclusion: root cause analysis we conclude that the cause of the problem could be produced as a consequence of a damage in the plunger lip.This could be produced during the handling of the product through the manufacturing process or in the plunger assembly machine.Confirmation no samples available for evaluation.No issue found in the bhr.We could not confirm the reported issue.Capa determination no - based on an evaluation of severity and occurrence it was determinate that no corrective action is required at this time.
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