CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM PROGRAMMABLE VALVE, RT ANGLE; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
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Catalog Number 82-3184 |
Device Problem
Device Operational Issue (2914)
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Patient Problem
No Information (3190)
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Event Date 01/10/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Upon completion of the investigation, a follow up report will be filed.
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Event Description
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As reported by the ous affiliate, a chpv and a bactiseal catheter did not work after being implanted.There were no reports of delay or patient harm.
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Manufacturer Narrative
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Updated udi (b)(4).The valve and catheters were returned for evaluation.The position of the cam when valve was received was 40mmh2o.The valve was visually inspected: needle holes in the needle chamber were noted.The valve was tested for programming and passed.The valve was flushed; no occlusions noted.The valve was leak tested and passed.The catheters were irrigated, no occlusions noted.The valve was reflux tested and passed.The valve was then pressure tested and passed.A review of manufacturing records found no discrepancies.Based on evaluation of the products, no device failure has occurred.The devices functioned as intended.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.Refer to mdr 1226348-2018-10102 for information regarding the second device associated with this event.
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Manufacturer Narrative
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The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.
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Search Alerts/Recalls
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