Model Number 20350E |
Device Problems
Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/10/2021 |
Event Type
malfunction
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Event Description
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It was reported that 2 bd alaris smartsite low sorbing extension sets was damaged, but still operable.The following information was provided by the initial reporter: "it was reported by customer that the tubing bends and fluid leaks out.".
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used as a default a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Manufacturer Narrative
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H.6.Investigation: a complaint of tubing bending and fluid leaking out was received from the customer.62 unused samples were returned for investigation.Through visual inspection, the customer complaint was confirmed.51 samples had issues with leakage or air bubbles during priming.There was also a large amount of solvent noticed at the connection site of the filter and tubing.Kinks were also observed on 11 samples where the pinch clamp is assembled.3 samples had no issues at all.A device history record review for model 20350e lot number 21059500 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause could be excessive solvent in the joint male luer - tubing.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of component damage with lot #21059500 regarding item 20350e.H3 other text : see h.10.
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Event Description
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It was reported that 2 bd alaris smartsite low sorbing extension sets was damaged, but still operable.The following information was provided by the initial reporter: "it was reported by customer that the tubing bends and fluid leaks out.".
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Search Alerts/Recalls
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