Catalog Number 515111 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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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 25 bd phaseal¿ protectors p50j experienced damaged or open unit packaging/seals where sterility was compromised.The following information was provided by the initial reporter: the customer (hospital) complains about damaged packaging.
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Manufacturer Narrative
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H.6.Investigation: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for lot 2003151, no deviations or non-conformances were identified during the manufacturing process.Retained samples of the same lot were inspected, no issues related to the packaging was identified.Product undergoes inspections throughout the manufacturing process, verifying there is no damage or holes, no documented incidents were reported for lot 2003151.Based on the available information we are not able to determine a root cause at this time.H3 other text : see h.10.
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Event Description
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It was reported that 25 bd phaseal¿ protectors p50j experienced damaged or open unit packaging/seals where sterility was compromised.The following information was provided by the initial reporter: the customer (hospital) complains about damaged packaging.
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Search Alerts/Recalls
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