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Model Number 8888145046P |
Device Problems
Break (1069); Product Quality Problem (1506)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/06/2018 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during procedure, the stylet broke off in the catheter¿s lumen at the proximal part.The catheter was removed and replaced by another catheter.The patient¿s new catheter worked, but during the second insertion of the stylet, the physician stated that it was also difficult to remove, the material of the stylet was stretched and almost broke off as well.The piece that broke off in the lumen within the catheter was removed from the patient and nothing was left behind.There was no patient injury.
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Manufacturer Narrative
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Evaluation summary: a device history review revealed no discrepancies that may have contributed to a complaint of this failure mode.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements.All dhr (device history review) are reviewed for accuracy prior to product release.One sample was provided.Visual evaluation of this sample was performed; and it was observed one stylet broken and showed signs of being manipulated.As part of the testing we tried to replicate according use of the labeling instruction.According to testing, if the guidewire was not removed first and it was tried to remove first, the stylet that was placed in the arterial lumen could exert a force that causes it to break that was similar to the reported defect.The product sample was returned for evaluation.The reported condition has been confirmed.A manufacturing defect could not be related to the reported condition.The most probable cause was identified as man/customer misuse inadequate manipulation of the components.No trends or triggers have been found.No action is deemed necessary at this time.It must be noted that in-process controls are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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