Catalog Number 395000 |
Device Problem
Free or Unrestricted Flow (2945)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/02/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that the connecta white 360deg shelf 100ea india had unregulated flow during use.The following information was provided by the initial reporter: "problem in connecta pressure pressure is not stable over 250psi, it comes back from 300psi to 250psi".
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Manufacturer Narrative
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H6: investigation summary: a device history record review was completed for provided lot number 9333986.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.The provided picture was not sufficient for a sample analysis as the picture only displayed the outer packaging information.Based on the provided customer feedback, it has been determined that excessive pressure was used on the product.This product is designed to withstand infusion therapy and hemodynamic monitoring pressure only, which is detailed within the instructions for use.H3 other text : see h10.
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Event Description
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It was reported that the connecta white 360deg shelf 100ea india had unregulated flow during use.The following information was provided by the initial reporter: "problem in connecta pressure.Pressure is not stable over 250psi, it comes back from 300psi to 250psi.".
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Search Alerts/Recalls
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