Catalog Number 385100 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/17/2024 |
Event Type
malfunction
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Event Description
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It was reported that the bd q-syte leaked.The following information was provided by the intial reporter translated from chinese to english: "normal use of infusion connector connected to the indwelling needle infusion, afterward infusion check found infusion connector at the leakage, stop using timely replacement.".
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Manufacturer Narrative
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H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
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Manufacturer Narrative
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Investigation results: the reported defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.A device history record review was completed by our quality engineer team for provided material number 385100 and lot number 2346125.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.This complaint type will continue to be trended within the post market surveillance process and any determined escalation will be managed there.
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Event Description
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No additional information.
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Search Alerts/Recalls
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