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 or about (b)(6)2020 it was reported to anika that during an injection of monovisc, the syringe tip connection broke and the medication leaked out.Only about half the solution was injected into the patient.There was no report of any patient or user impact.There was no delay in the procedure reported.The device was not returned to the manufacturing plant for analysis.
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