Model Number 8884715122E |
Device Problems
Fluid/Blood Leak (1250); Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/14/2022 |
Event Type
malfunction
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Event Description
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The customer reported that the tube had a leak and they verified it via the breakage of the union of the key.The patient was a male under the age of one.He was in the hospital with a medical diagnosis of mixed chronic malnutrition, neurogenic dysphagia and dilatated heart disease.Per additional information received, there was no medical intervention required.There was no patient injury reported."breakage of the union of the key" refers to the tube rupturing.
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Manufacturer Narrative
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An investigation is currently underway.Upon completion, the results will be forwarded.
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Manufacturer Narrative
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The device history record (dhr) file was reviewed, and no discrepancy was found according to the issue reported.Sample analysis could not be performed since no photos or physical sample was available for evaluation.The complaint will be reopened if sample is received at a later date.Since the sample has not been received for evaluation, the reported issue could not be confirmed.However, a corrective and preventive action has been initiated to address the issue.
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Manufacturer Narrative
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Added fluid leak code to section h6.Medical device problem code.
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Search Alerts/Recalls
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