Catalog Number 0250080231 |
Device Problem
Device Packaging Compromised (2916)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/22/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacture date is not known at this time.However, if it should become available, it will be provided in future reports.Additional information will be provided once the investigation has been completed.(b)(4).
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Event Description
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It was reported that the insulation had been compromised.
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Manufacturer Narrative
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The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Alleged failure: cib ryan pcs.Insulation (b)(4).The failure identified in the investigation is consistent with the complaint record.The probable root cause could be improper cleaning or sterilization, or normal wear.Manufacture date is not known.
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Event Description
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It was reported that the insulation had been compromised.
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Search Alerts/Recalls
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