Catalog Number 8065751617 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/02/2024 |
Event Type
malfunction
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Event Description
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A nurse reported faulty vitrectomy tubing, it showed abnormal detachment of tubing during calibration set-up.There was no patient contact.Another vitrectomy set was opened and surgery was completed.There was no report of patient harm.
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The auto infusion valve (aiv) tubing manifold was returned and visually inspected.Visual inspection confirmed a weak weld between the top and base of the auto infusion valve which can result in the customer's experience.Supplier was notified of the defect and accepted the non-conformance.The supplier¿s root cause for the customer complaint was suboptimal welding parameters configuration coupled with ineffective inspection method and the use of the incompatible top and base batches resulted in the customer¿s experience.This batch is part of pre-corrective action product.The supplier manufacturer investigation was completed and additional controls within the manufacturing process have been implemented to reduce the frequency of the weak weld for the aiv.Enhancements to testing, inspection methods, and process parameters are part of the additional controls that were implemented.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is:(b)(4).
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Search Alerts/Recalls
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