MAUDE Adverse Event Report: CARDINAL HEALTH ENTRFLX 10FR 43IN W STY YPORT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884721088E

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/05/2023

Event Type  Injury  

Event Description

The customer reported through medwatch that a retained foreign object was found and collected during an esophagogastroduodenoscopy (egd)/colonoscopy 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, the patient was intubated for airway protection.After intubation, an endoscope was reintroduced and using a cold snare, the 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 the ng and the ng had come out a few inches.The rn attempted to advance it 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 the 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 the radiologist in the x-ray report.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

The device history record (dhr) review could not be performed because no lot number was provided.A sample evaluation could not be performed because no sample nor photo was available.The complaint will be reopened if a sample is received.The reported condition could not be confirmed.All process and controls were found properly followed.A root cause could not be determined with the available information.No further actions are required.This complaint will be used for tracking and trending purposes.

• Brand Name: ENTRFLX 10FR 43IN W STY YPORT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18408878
• MDR Text Key: 331489682
• Report Number: 9612030-2023-03886
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521582996
• UDI-Public: 10884521582996
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 12/18/2023
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 69 KG