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Model Number 8884711501 |
Device Problem
Complete Blockage (1094)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/13/2022 |
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.
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Event Description
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The customer reported that a doctor inserted a new feeding tube into a patient but was unable to aspirate gastric content from the side port.The tube was then removed from the patient and the users tried to flush both ports and realize that the side port is occluded, neither air nor water could be flushed through the side port.A new feeding tube from the same lot was opened and inserted into same patient and both ports in the newly opened tube was working well.No patient injury.
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Manufacturer Narrative
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A sample was not returned for evaluation.The device history record (dhr) file was reviewed, and no discrepancy was found according to the reported issue.The manufacturing process was reviewed.All processes and controls were found properly followed, including sub-assemblies, finished product assembly, packaging and inspections performed to the product.There were no abnormal conditions found that could trigger the reported condition.Furthermore since no samples or photos were returned, the reported issue could not be confirmed, and a possible root cause cannot be determined.If a sample is returned at a later date the investigation will be updated accordingly.Based on the available information, an action plan is not required at this time.The complaint will be used for tracking and trending purposes.
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Manufacturer Narrative
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A sample was not returned for evaluation.The device history record (dhr) file was reviewed, and no discrepancy was found according to the reported issue.The manufacturing process was also reviewed.All processes and controls were found properly followed, including sub-assemblies, finished product assembly, packaging and inspections performed to the product.There were no abnormal conditions found that could trigger the reported condition.Based on the available information and since no samples or photos were returned, the reported issue could not be confirmed, and a possible root cause cannot be determined.If a sample is returned at a later date, the investigation will be updated accordingly.No action plan is required at this time.This complaint will be used for tracking and trending purposes.
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Search Alerts/Recalls
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