Catalog Number 394900 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/20/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that 2 bd connecta plus stopcocks' caps were loose and detached upon opening the package.The following information was provided by the initial reporter: "the cap was loose and detached upon package opening.This issue was observed in several products from lot #1210937b.".
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Manufacturer Narrative
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H6: investigation summary since no photos or samples displaying the reported condition of loose component - no leak were available for examination, we were unable to fully investigate this incident.The device history records (dhr) review was performed for the lot number material identified in this complaint.According to the documented records, the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.
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Event Description
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It was reported that 2 bd connecta plus stopcocks' caps were loose and detached upon opening the package.The following information was provided by the initial reporter: "the cap was loose and detached upon package opening.This issue was observed in several products from lot #1210937b.".
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Search Alerts/Recalls
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