Catalog Number 381412 |
Device Problems
Leak/Splash (1354); Failure to Advance (2524); Material Twisted/Bent (2981)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/02/2019 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that the plastic sheath of a bd¿ insyte autoguard was bent and could not be advanced.After discontinuation, it was noticed that the iv was leaked from the "bend".
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Manufacturer Narrative
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Investigation: review of dhr revealed all required challenge samples, set-up and in process testing was performed in accordance with the quality plans.Review disclosed no reject activity findings throughout the build of this lot that would impact the outcome of the quality of the product relevant to the defect stated in the pir.Observations and testing could not be performed because units were not received for investigation of this incident.Without the actual sample for evaluation and testing there was no physical evidence to confirm or support manufacturing process related issues for the reported defect.
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Event Description
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It was reported that the plastic sheath of a bd¿ insyte autoguard was bent and could not be advanced.After discontinuation, it was noticed that the iv was leaked from the "bend".
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Search Alerts/Recalls
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