CARDINAL HEALTH DOBHFF 8FR 43IN W STYLTY SITE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
|
Back to Search Results |
|
Model Number 8884710859 |
Device Problem
Difficult to Remove (1528)
|
Patient Problems
Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/14/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
An investigation is currently underway.Upon completion, the results will be forwarded.
|
|
Event Description
|
The customer reported that they inserted dobhoff nasogastric tube and went to remove the guidewire and it was stuck.The cardinal health sales rep visited with intensive care unit (icu) and emergency room (er), the staff stated that they had to take out the tube and insert a new one.In this case, an order was received to discontinue the ng tube and await surgical placement of peg.The patient was alert and oriented, the procedure was uncomfortable and due to the malfunction, feeding could not be initiated.The nurse and the provider completed verbal apology and service recovery.There was no patient harm reported.
|
|
Manufacturer Narrative
|
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The device was manufactured on 11-oct-2019.A sample was not received for the investigation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.At this time, a corrective and preventive action is not deemed necessary.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.
|
|
Manufacturer Narrative
|
Section b3 (date of event): originally reported by the customer was incorrect.The exact event date for the reported incident is unknown.Section h6 (health effect - clinical code): originally reported as 4582 no clinical signs, symptoms or conditions and should be 2330 discomfort.
|
|
Search Alerts/Recalls
|
|
|