Model Number 100/810/080 |
Device Problems
Break (1069); Crack (1135)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Manufacturer Narrative
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Date of event is unknown, no information has been provided to date.Investigation, including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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It was reported that the cannula was showing cracks in the body of the sub cannula, making it unusable for the patient.In addition, the sub cannula for hygienization also breaks easily and prevents the replacement of the sub cannula when necessary.This is causing frequent exchange of cannulas.Customer reports that training is periodically provided for this material.A total of 6 complaints were created to document this report.
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Manufacturer Narrative
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Other, other text: h6.Event problem and evaluation codes: updated.Investigation of this complaint was limited because no sample was provided.Two (2) photos were provided where a crack of inner cannula across its length is visible.No trend of complaints related to inner cannula crack has been received.A device history record (dhr) review showed no discrepancies were reported during manufacturing for the reported lot number.The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined.
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Search Alerts/Recalls
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