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

Model Number	8884721088E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/05/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional 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
• Common Device Name: 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
• Report Number: 9612030-2023-03886
• Device Sequence Number: 8766908
• Product Code: KNT
• UDI-Device Identifier: 10884521582996
• UDI-Public: 10884521582996
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 01/22/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 69 KG