Catalog Number 394600 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/14/2022 |
Event Type
malfunction
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Event Description
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It was reported that the bd connecta¿ stopcock female connection came loose and caused leakage.The following information was provided by the initial reporter: "drip in connections.During use, the female connection came loose and a leak was created in the connections.".
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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 - 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 the bd connecta¿ stopcock female connection came loose and caused leakage.The following information was provided by the initial reporter: "drip in connections.During use, the female connection came loose and a leak was created in the connections.".
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Search Alerts/Recalls
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