Model Number 5540 |
Device Problem
Separation Problem (4043)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Langston v2 catheter was returned for evaluation.Investigation is in progress; when results or further information is received a follow-up report will be submitted.
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Event Description
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It was reported that a power injection was done at 800 psi and the catheter fractured in between the hub and the y port.No further complications were reported.
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Manufacturer Narrative
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A returned product evaluation was completed and confirmed excess adhesive was present on the inner catheter shaft and likely caused the reported event.The inner catheter shaft was separated just distal to the proximal device hub.The root cause was traced to supplier manufacturing process.
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Search Alerts/Recalls
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