Model Number 2420-0007 |
Device Problems
Material Separation (1562); Separation Failure (2547)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
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Event Date 12/15/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.
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Event Description
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It was reported that 2 safe sets where the plunger had separated from the rubber tip.There is no report that patient care was delayed and that it did not contribute to, or result in serious adverse impact to patient.
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Manufacturer Narrative
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The customer¿s report that the plunger had separated from the rubber tip was confirmed during visual inspection of both primary sets model 2420-0007.The customer¿s description of ¿plunger separated from the rubber tip¿ was determined to be tubing separation from the inlet port of the proximal smartsite.The sets were visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Further visual inspection using a microscope observed insufficient solvent on the tubing.Functional testing was not performed due to the separated tubing.The root cause of the separation was identified as a manufacturing issue for insufficient solvent being applied at the engagement of the tubing to the smartsite inlet due to equipment and/or operator error.
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Event Description
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It was reported that (2) safe sets separated at the proximal y-site inlet port.There was no report that patient care was delayed and was also confirmed during follow up, that this event did not contribute to, or result in serious adverse impact to patient.
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Search Alerts/Recalls
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