Catalog Number 0380542150 |
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 09/20/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
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Event Description
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It was reported that there was foreign material in the sterile packaging.
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Manufacturer Narrative
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Alleged failure: there was a small red piece of something on the tip the failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause/s could be improper cleaning process, qc incoming, and in-process inspections, environmental conditions.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
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Event Description
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It was reported that there was foreign material in the sterile packaging.
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Search Alerts/Recalls
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