CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM VENTRICUALR & PERITONEAL CATHETERS WITH BACTISEAL; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
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Catalog Number 82-3072 |
Device Problem
Device Operational Issue (2914)
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Patient Problem
No Information (3190)
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Event Date 06/09/2017 |
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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Shunt malfunction post implantations.
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Manufacturer Narrative
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It was not possible to investigate the complaint as no sample was returned for evaluation.Numerous attempts were made to recover the device, with no success.If the samples are returned in the future, this complaint will be re-opened and evaluated.Review of the history device records confirmed the valve product code 82-3184 with lot cvlbn7, conformed to the specifications when released to stock on the 19th october 2016.A search for relative complaint for the bactiseal catheter was not possible as the lot number was unknown.The review of the dhr for the bactiseal catheter was not possible as the lot number give could not be found in our system.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.
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Manufacturer Narrative
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It was previously reported that the device would not be returned.The device was subsequently provided.This report has been updated to reflect the corrected information.Upon completion of the investigation, a follow-up report will be submitted.
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Manufacturer Narrative
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It was previously reported that the device would not be returned.The device was subsequently provided.This report has been updated to reflect the corrected information.Upon completion of the investigation, a follow-up report will be submitted.
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Manufacturer Narrative
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Upon completion of the investigation it was noted that the images were taken of the ¿as received¿.The position of the cam when valve was received was 30 mmh2o.The valve was visually inspected: needle holes in the needle chamber were noted.The valve was hydrated.The valve was tested for programming with programmer 82-3126 with serial (b)(4), the valve passed the test.The valve was flushed, the valve passed the test no occlusion was noted.The valve was leak tested, only leak from the needle holes in the needle chamber was noted.The catheters were irrigated, no occlusions were noted.The valve was reflux tested.The valve passed the test.The valve was dried.The valve was then pressure tested, the valve passed the test.Review of the history device records confirmed the valve product code 82-3184, with lot cvlbn7, conformed to the specifications when released to stock in october 19th, 2016.Review of the history device records of product code 82-3072 with lot 1155727, was not performed as this lot number could not be found in our system.No root cause could be determined, as the problem reported by the customer could not be duplicated with the valve or the bactiseal catheters.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.
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Manufacturer Narrative
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Upon completion of the investigation it was noted that the images were taken of the ¿as received¿.The position of the cam when valve was received was 30 mmh2o.The valve was visually inspected: needle holes in the needle chamber were noted.The valve was hydrated.The valve was tested for programming with programmer 82-3126 with serial (b)(4), the valve passed the test.The valve was flushed, the valve passed the test no occlusion was noted.The valve was leak tested, only leak from the needle holes in the needle chamber was noted.The catheters were irrigated, no occlusions were noted.The valve was reflux tested.The valve passed the test.The valve was dried.The valve was then pressure tested, the valve passed the test.Review of the history device records confirmed the valve product code 82-3184, with lot cvlbn7, conformed to the specifications when released to stock in october 19th, 2016.Review of the history device records of product code 82-3072 with lot 1155727, was not performed as this lot number could not be found in our system.No root cause could be determined, as the problem reported by the customer could not be duplicated with the valve or the bactiseal catheters.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.
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