Catalog Number 406049 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/01/2018 |
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 and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that bd¿ continuous epidural tray epid cont we18g3.5 c20 lor5 p drape had a failing connector that separated.No serious injury or medical intervention was reported.
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Manufacturer Narrative
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Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history review could not be completed as no batch number was provided.Investigation conclusion: unable to determine a root cause.Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacturer: no.
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Event Description
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It was reported that bd¿ continuous epidural tray epid cont we18g3.5 c20 lor5 p drape had a failing connector that separated.No serious injury or medical intervention was reported.
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Search Alerts/Recalls
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