MAUDE Adverse Event Report: CARDINAL HEALTH KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884721088E

Patient Problem Foreign Body In Patient (2687)

Event Date 09/05/2023

Event Type  malfunction  

Event Description

A retained foreign object was found and collected during an esophagogastroduodenoscopy (egd)/colonscopy performed to rule out a gastrointestinal bleed.The distal 10cm of a nasoenteric tube was found in the gastric fundus.Given necessity for removal of foreign body, patient was intubated for airway protection.After intubation, endoscope was reintroduced and using a cold snare, feeding tube fragment was successfully retrieved.Endoscope once more reinserted and no evidence of any mucosal injury from retrieval was noted.The examined duodenum was normal.Unfortunately, the tube was not saved¿it was discarded.Root cause analysis of event: during the hospitalization of the patient, the nasogastric (ng) tube was pulled out multiple times and replaced.Patient had pulled on ng and ng had come out a few inches.Rn attempted to advance back in without completely removing the ng.After the rn advanced, she ordered an x-ray to recheck placement.The radiologist had documented fragment of distal portion of the feeding tube was present within the stomach, but this information apparently was not communicated to the patient's physician.Days later, during the night shift, the doctor reported that the ng tube would not be replaced at this time and will be deferred to day team.Imaging had reported the tube fragment on x-rays, however this finding was not communicated to physicians.On the afternoon, the ng tube was placed and confirmed placement with x-ray.Again, a fragment of the distal portion of feeding tube was noted by radiologist in x-ray report.This facility has developed a corrective action plan to address breakdown in communication and charting/documentation omissions along with role specific duties.

• Brand Name: KANGAROO
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 18344060
• MDR Text Key: 330717264
• Report Number: 18344060
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/26/2023,10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884721088E
• Device Catalogue Number: 8884721088E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/26/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29200 DA
• Patient Sex: Male
• Patient Weight: 69 KG