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Model Number 21-2961-24 |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/01/2021 |
Event Type
malfunction
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Event Description
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It was reported, that the customer infused medical fluid (physiological saline solution) into the patient through the product using a syringe.But backflow of medical fluid was not observed.So the customer removed the product from the patient, and passed medical fluid through the product with the syringe connected.However, at that time, medical fluid was unable to be drawn (only air bubble were drawn).No patient injury was reported.
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Manufacturer Narrative
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This remediation mdr was generated under protocol b10010116, as a result of warning letter cms# 6(b)(6).No problems or issues were identified during this device history record review.One sample was received, decontaminated.The sample was received in used condition with its original package.During the functional testing, no occlusion was detected.The complaint was not confirmed.Root cause: based on the analysis conducted in the sample provided, the complaint was not confirmed.
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Search Alerts/Recalls
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