Model Number EN0046140 |
Device Problem
Insufficient Information (3190)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/29/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that the nasogastric tube did not do what intended in medical setting.The issue with the nasogastric tube was unknown.The product catalog numbers provided by customer were en0046100, en0046120, en0046140, en0046160 and en0046180.
|
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
|
|
Manufacturer Narrative
|
The reported event was inconclusive because no sample was returned.A potential root cause was not chosen due to a lack of information.It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.A labeling review was not completed due to a lack of information.The device was not returned.
|
|
Event Description
|
It was reported that the nasogastric tube did not do what intended in medical setting.The issue with the nasogastric tube was unknown.The product catalog numbers provided by customer were en0046100, en0046120, en0046140, en0046160 and en0046180.
|
|
Search Alerts/Recalls
|