Catalog Number CAT02438 |
Device Problem
Crack (1135)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/21/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.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 the cannula cracked during the procedure.
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Event Description
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It was reported that the cannula cracked during the procedure.
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Manufacturer Narrative
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The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: seam where polymer tip meets metal shaft of flowport cannula broke.Probable root cause: design - inadequate material selection to support movement/manipulation by user - inadequate molding/assembly design, poor strength of design manufacturing - cannula not assembled, molded or machined to specification application - excessive force the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
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Search Alerts/Recalls
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