Catalog Number VASCULAR UNKNOWN |
Device Problems
Obstruction of Flow (2423); Material Deformation (2976); Material Too Soft/Flexible (4007)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190)
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Event Date 08/01/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Catalog number and lot number unknown at the time of this report.Awaiting additional information to confirm catalog and lot number.
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Event Description
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The customer reports several incidents of the lines kinking and obstructing the flow of noradrenaline having an impact on the patients.The customer notes the kinking below the hub and above the skin.They noted that when the catheter body got very warm it became very malleable.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed because a sample was returned for analysis.A device history record review could not be performed as a product code and lot number were not provided.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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Event Description
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The customer reports several incidents of the lines kinking and obstructing the flow of noradrenaline having an impact on the patients.The customer notes the kinking below the hub and above the skin.They noted that when the catheter body got very warm it became very malleable.
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Search Alerts/Recalls
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