Model Number 8884711253 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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Customer reports: there were impairments of the administration of enteral diet and medications due to the tube folding inside the patients.The patients were exposed to a new enteral tube and its risks, as well as exposure to a new radiological examination.This event was repeated in several patients.
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Manufacturer Narrative
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Device evaluation comment - this case was received through brazil's anvisa site from an unidentified source therefore it is not possible to request samples for evaluation.An investigation is currently underway.Upon completion, the results will be forwarded.
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Manufacturer Narrative
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A review of the device history record (dhr) revealed no abnormal process conditions were present during the manufacturing of the product that could have led to the condition described by the customer.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.There were no samples nor photographs received for evaluation therefore the reported condition could not be confirmed, nor could a root cause be determined.A corrective/preventative action plan is not required since the reported condition has not been identified as manufacturing related.The current process is running according to product specifications meeting quality acceptance criteria.We will continue monitoring the process for any adverse trends that require immediate attention.
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Search Alerts/Recalls
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