Catalog Number 394602 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/09/2022 |
Event Type
malfunction
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Event Description
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It was reported that 2 bd connecta¿ stopcock 3-way end cap was loose and falls off during use.The following information was provided by the initial reporter, translated from (b)(6) to english: the end cap on the rear of the product is loose and falls off during use.
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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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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¿ stopcock 3-way end cap was loose and falls off during use.The following information was provided by the initial reporter, translated from chinese to english: the end cap on the rear of the product is loose and falls off during use.
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Search Alerts/Recalls
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