Catalog Number 630254 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/26/2024 |
Event Type
malfunction
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Manufacturer Narrative
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This case is still under investigation.Additional information was solicited.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.
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Event Description
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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 28feb2024 the distributor reported to anika that an orthovisc syringe plunger broke during the injection.It is unknown if the glass syringe broke during the injection.There was no negative patient or user impact reported.There was no report of any unusual appearance with the device or packaging prior to use.Additional information was solicited.
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Manufacturer Narrative
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This case is still under investigation.Additional information was solicited.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.The reported event is not confirmed.It was reported that the plunger broke during a procured on a patient of unknown age and demographics.There was no negative patient or user impact reported.The device was not returned to the manufacturing plant for analysis.The lot number is unknown.A review of the batch record could not be performed.All product manufactured by anika is released to applicable procedures and specifications.A three-year retrospective review of nonconformances for the product was performed.There was no nonconformances related to the reported event.A three-year retrospective review of the retention inspection was performed.There was no nonconformances related to the reported event documented in the logs.A review of the stability study report for (orthovisc) was performed.There was no nonconformances documented in the stability study report.The conclusion for the product stated that the product has met all required specifications and tolerances.A supplemental report will be submitted upon receipt of new and relevant information.The reported event will continue to be monitored and trended for future analysis.
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Event Description
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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) 2024 the distributor reported to anika that an orthovisc syringe plunger broke during the injection.It is unknown if the glass syringe broke during the injection.There was no negative patient or user impact reported.There was no report of any unusual appearance with the device or packaging prior to use.Additional information was solicited.
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Search Alerts/Recalls
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