11G IVAS ACCESS CANNULA

Additional Manufacturer Narrative

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. REPORTED EVENTS 3 EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS 2 DEVICES WERE NOT AVAILABLE FOR EVALUATION. 1 DEVICE WAS EVALUATED USING DATA PROVIDED BY THE USER OR THIRD PARTY. EVALUATION FINDINGS (RESULTS/COMPONENTS) 2 DEVICES: FRACTURE PROBLEM / CANNULA 1 DEVICE: NO FINDINGS AVAILABLE / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE PRODUCT DISPOSITION 3 DEVICES: SCRAPPED BY CUSTOMER ADDITIONAL INFORMATION 3 DEVICES WERE LABELED FOR SINGLE-USE. 3 DEVICES WERE NOT REPROCESSED OR REUSED.

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 3 EVENTS FOR THE FAILURE: FRACTURE. - 3 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.