Catalog Number 0620040690 |
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 11/27/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported that there was foreign material inside of the sterile packaging.
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Manufacturer Narrative
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Alleged failure: (b)(4) hair in the sterile packaging salesforce case number (b)(4).The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be foreign material fell inside during packaging.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.
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Event Description
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It was reported that there was foreign material inside of the sterile packaging.
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Search Alerts/Recalls
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