Catalog Number 383516 |
Device Problems
Fail-Safe Design Failure (1222); Mechanical Problem (1384)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/15/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.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 during use a bd nexiva¿ closed iv catheter system malfunctioned as ¿the safety mechanism on nexiva did not activate and would not release from the hub of the catheter.¿there was no report of exposure, injury or medical intervention needed.
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Manufacturer Narrative
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Visual/microscopic examination revealed damage to the back end of the catheter adapter which prevented the tip shield from decoupling upon full retraction of the needle.The customer's experience was confirmed and reproduced.Dhr review - a review of the dhr could not be performed as no batch number was provided.The damage can occur at stations which come into contact with the back end of the catheter adapter if the part or tooling is misaligned.
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Search Alerts/Recalls
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