Model Number 7771610E |
Device Problem
Complete Blockage (1094)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 08/30/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
|
|
Event Description
|
The customer reported that the enfit multifunction port was not suctioning properly.The gastric content was getting stuck or clogged in the suction port and preventing the suction to occur.The hole is small and the gastric content is too thick to suction through.
|
|
Manufacturer Narrative
|
Additional information: a review of the device history record (dhr) could not be conducted because a lot number was not provided.A picture was provided for evaluation.However, the issue is not able to be confirmed from the picture alone.If a sample is received in the future, the complaint will be reopened.The root cause of the reported condition could not be determined from evaluating the picture alone.No corrective actions are deemed necessary at this time.The manufacturing site will continue monitoring the process for any adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.
|
|
Search Alerts/Recalls
|