This complaint is in scope of a complaint remediation project and has been identified as a complaint that required a mdr based on either the source of the complaint or the type of complaint and is being reported.This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report does not reflect a conclusion by anika or its employees that the report constitutes an admission that the device, anika, or its employees caused or contributed to a potential patient event documented on this report.On (b)(6) 2019 the distributor reported to anika that a monovisc syringe broke at the leur lock location of the syringe during an injection.A 20gauge syringe was being used for the injection.There was no appearance issues or leakages observed prior to use of the device.There was no negative patient impact and no delay in the procedure.
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