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Model Number MCS20 |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.Attempts have been made to retrieve the device.To date, the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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It was reported that during an open biliary surgery, since the packaging was faulty when it was opened, the contents became unsterile and could not be used.There was no patient consequence.
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Manufacturer Narrative
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(b)(4).Investigation summary: the analysis results found that a mcs20 device was returned inside its original package.Upon visual inspection, it was noted that the tyvek was adhered to the blister in the easy opening area.Possible causes of tyvek delamination are tyvek quality, seal strength, or opening technique; however, no conclusion could be reached as to what may have caused this condition.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.
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Search Alerts/Recalls
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