Catalog Number 1212.08 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/11/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The malfunctioning sample was not returned, but a malfunctioning sample of a different length has been returned to vygon for evaluation as part of the complaint investigation.The results of this investigation are still pending, and will be communicated to fda within thirty days of its conclusion via follow-up mdr.
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Event Description
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Catheter found broken.Patient is ok according to customer contact.
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Manufacturer Narrative
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This complaint is not confirmed.The complaint and returned sample have been submitted to vygon (b)(4), which is where this part was manufactured, for evaluation.The following is the report of their investigation.An examination of the returned sample shows that the extension line had been torn out of its ll-hub.The proximal end of the extension line has typical signs of a sufficient molding into the hub.Partly rounded edges, marks of the distal end of the hub and the widened end of the tube are typical signs for this finding.The breaking force between ll-hub and extension line should be a minimum of 10n.For the involved batch the range of the tensile force between extension line and ll-hub was between the minimum of 13.59n and the maximum of 31.00n.The batch history did not show any abnormities.This is the first complaint for batch (b)(4) and the second for code 1212.08 regarding the described defect within the last 14 years.A manufacturing fault can be excluded for this kind of defect as this is an isolated event.Corrective/preventative action: no further corrective action initiated by quality management.Vygon will continue to monitor this type of complaint in their complaint tracker.
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Event Description
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Catheter placed on (b)(6), and found broken on (b)(6).Patient is ok according to customer contact.
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Search Alerts/Recalls
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