CODMAN & SHURTLEFF, INC. HAKIM VENTRICUALR & PERITONEAL CATHETERS WITH BACTISEAL; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
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Catalog Number 82-3072 |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/03/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).It has been reported that the device will not be returned for evaluation.A lot number has been provided.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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As reported by the affiliate, a bactiseal catheter connected to a strata valve would not drain.Surgeon, remembering the ifu recommends flushing the catheter prior to use, disconnected the valve and flushed all the components.The valve was then implanted without any issues, causing a delay of 10-20 minutes.There were no reports of patient harm.The product will not be returned.
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Manufacturer Narrative
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(b)(4).Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records found no discrepancies related to the reported issue.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.
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