AVAFLEX CURVED NEEDLE W/ CANNULA

Description of Event or Problem

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1 ¿ MARCH 31 2026. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

Additional Manufacturer Narrative

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. REPORTED EVENTS 1 EVENT WAS REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS 1 DEVICE INVESTIGATION TYPE HAS NOT YET BEEN DETERMINED. EVALUATION FINDINGS (RESULTS/COMPONENTS) 1 DEVICE: RESULTS PENDING COMPLETION OF INVESTIGATION / NEEDLE PRODUCT DISPOSITION 1 DEVICE: PRODUCT DISPOSITION IS NOT YET DETERMINED ADDITIONAL INFORMATION 1 DEVICE WAS LABELED FOR SINGLE-USE. 1 DEVICE WAS NOT REPROCESSED OR REUSED.