Model Number 270.04 |
Device Problems
Complete Blockage (1094); Obstruction of Flow (2423)
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Patient Problem
No Information (3190)
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Event Date 10/01/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The malfunctioning device will be returned to vygon for evaluation as part of the complaint investigation.The user wrote that it could be a device quality defect or an event not related to the devices.The batch review shows that it complies to its specifications.All these umbilical catheters are 100% tested for non-obstruction during the manufacturing process.Furthermore, the retained sample has been checked, it is compliant.No catheter obstruction were noticed.We have also checked our complaint's history, these are the first complaints on this batch.
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Event Description
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After insertion of the umbilical catheter, there was no veinous blood return.The umbilical catheter has been withdrawn and replaced by a second one.
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Event Description
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After insertion of the umbilical catheter there was no veinous blood return.The umbilical catheter has been withdrawn and replaced by a second one.
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Manufacturer Narrative
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The sample for the event#: (b)(4) was not kept.Therefore further investigation is not possible.The root cause of the obstruction cannot be defined.It seems not be linked to a device defect.The batch review shows that it complies to its specifications.All these umbilical catheters are 100% tested for non-obstruction during the manufacturing process.Furthermore, the retained sample has been checked, it is compliant.No catheter obstruction were noticed.We have also checked our complaint's history, these are the first complaints on this batch.
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Search Alerts/Recalls
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