Catalog Number 400713 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/16/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).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 with the use of the bd durasafe¿ combined anesthesia kit there was an issue with foreign matter.
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Event Description
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It was reported with the use of the bd durasafe combined anesthesia kit there was an issue with foreign matter.
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Manufacturer Narrative
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A device history review was conducted for lot number 7226559.Our records show it was manufactured in aug- 2017, and determined that this is the second instance of a damaged packaging occurring in this lot.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections of packaged goods.With the photo submitted by the facility bd engineers were able to identify a possible fracture in the webbing of the packaging.Additionally a review of our manufacturing process determined that this originates in the supplied raw materials.Bd contacted our supplier, they confirmed the root cause is related to their manufacturing process.In response they have notified the appropriate personnel in an effort to prevent the reoccurrence of this event.Bd will continue to track and trend for this issue.
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Search Alerts/Recalls
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