Catalog Number OEM UNKNOWN |
Device Problem
Break (1069)
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Patient Problem
No Information (3190)
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Event Date 12/01/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.
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Event Description
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The bullet broke during a procedure.The patient's condition was reported as unknown.
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Manufacturer Narrative
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(b)(4).A dhr review could not be conducted since the lot number was not provided.A failure mode duplication could not be conducted at this time, due to the complaint stating an interaction with capio device, which is a device from customer (boston scientific) and not from teleflex plant.No corrective actions can be implemented due the lack of product sample and batch number to perform a proper investigation and determine the root cause.Customer complaint cannot be confirmed due the lack of product sample and batch number to perform a proper investigation and determine the root cause.
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Event Description
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The bullet broke during a procedure.The patient's condition was reported as unknown.
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Search Alerts/Recalls
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