Catalog Number 394605 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/02/2022 |
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 the bd connecta¿ stopcock 3-way experienced leakage.The following information was provided by the initial reporter, translated from (b)(6) to english: the connecta leak was found during the inspection of the infusion.
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Manufacturer Narrative
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H6: investigation summary: since no photos or samples displaying the reported condition of leakage 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 3-way experienced leakage.The following information was provided by the initial reporter, translated from chinese to english: the connecta leak was found during the inspection of the infusion.
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Search Alerts/Recalls
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