Sections with additional information as of 24-june-2021.H2 device evaluated by manufacturer.H6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: two syringes arrived with unknown liquid substance inside both syringes.Pci tech did not perform any testing as there were unknown substances inside the syringes.Returned product was forwarded to supplier quality to contact the manufacturer.Manufacturer's investigation has been completed, report attached and root cause selected.Per manufacturer's report, defect found on both syringes; unable to aspirate due to improper storage of the chemical liquid in the cylinder causing syringe to be clogged.Most likely underlying root cause mlc-061 improper use/mishandle by end user.
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