Catalog Number 401386 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/21/2020 |
Event Type
malfunction
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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.(b)(4).
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Event Description
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It was reported that the anesthesia tray continuous epidural experienced leakage.The following information was provided by the initial reporter: defect in the filter of the epidural catheter, the filter showed a leak at the time of the medication infusion.
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Event Description
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It was reported that the anesthesia tray continuous epidural experienced leakage.The following information was provided by the initial reporter: defect in the filter of the epidural catheter, the filter showed a leak at the time of the medication infusion.
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Manufacturer Narrative
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H.6.Investigation: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.A review of the device history record was performed and no quality issues were found during production.See h.10.
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Search Alerts/Recalls
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