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Model Number 8888256503 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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An investigation is currently underway.Upon completion, the results will be forwarded.H3: device evaluation comment - the customer stated that the device will not be returned for evaluation but did not provide rationale.
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Event Description
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Customer reports: there was an incident with a replogle catheter.This involved a tear in the material, which we use as a connecting element.
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Manufacturer Narrative
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Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.
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Manufacturer Narrative
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Based on the information available to us, the device history record review could not be reviewed since no lot number was provided from the customer.The physical sample was not returned; however, an image was submitted for evaluation.Based on this analysis, a blue tube (pigtail) with a mark can be observed confirming the reported issue.In order to determine a root cause, a gemba walk was done at the manufacturing facility focusing on the manufacturing equipment and process, however the root cause is undetermined.As a corrective/preventative action, personnel production received an awareness notification about the reported condition.The manufacturing site will continue to monitor customer complaints and feedback notifications for adverse trends that require immediate attention.Updated section h6: investigation findings - previously reported as code 213 should be code 180.Updated section h6: investigation conclusions - previously reported as code 67 should be code 4315.Updated section h10: additional manufacturer narrative - additional information added.
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Search Alerts/Recalls
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