Catalog Number 394910 |
Device Problems
Leak/Splash (1354); Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/14/2022 |
Event Type
malfunction
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Event Description
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It was reported that the cap was loose on the bd connecta¿ plus stopcock, leading to leakage.This event occurred 36 times.The following information was provided by the initial reporter, translated from japanese: the dimension of the male luer was too large to apply lock ring, causing leakage.
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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.
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Event Description
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It was reported that the cap was loose on the bd connecta¿ plus stopcock, leading to leakage.This event occurred 36 times.The following information was provided by the initial reporter, translated from japanese: "the dimension of the male luer was too large to apply lock ring, causing leakage.".
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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 - leak were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.
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Search Alerts/Recalls
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