MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884720858E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the section of the tube with the weight detached from the tube and remained in the patient's stomach.A consultation had to be carried out with anesthesia and gastroenterology for follow up.They are awaiting evaluation for sedation with gastroscopy or surgery under general anesthesia.Per additional information provided on november 25, 2025, they are waiting for the end of the tube to come out through the natural channels.They take x-rays regularly to follow the patient's journey.The patient is stable and doing well.He should be transferred to pediatrics shortly.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
One incomplete device was received for investigation.Only a portion of the tube was received, the tip of the tube where the bolus should be was not received.The reported condition was confirmed.The device history record (dhr) could not be reviewed as no lot information was provided within the complaint.However, prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.During production, inspectors routinely examine a statistical sample both physically and visually.As part of the investigation all processes and controls were reviewed and found to be correctly followed.There were no abnormal conditions found that could trigger the reported condition.Based on all available information, a definitive root cause could not be determined at this time.We will continue to monitor related reports to determine if additional actions are necessary.
Event or Problem Description
The customer reported the section of the tube with the weight detached from the tube and remained in the patient's stomach.A consultation had to be carried out with anesthesia and gastroenterology for follow up.They are awaiting evaluation for sedation with gastroscopy or surgery under general anesthesia.Per additional information provided on november 25, 2025, they are waiting for the end of the tube to come out through the natural channels.They take x-rays regularly to follow the patient's journey.The patient is stable and doing well.He should be transferred to pediatrics shortly.Per additional information provided on december 08, 2025, the patient has passed the tip naturally.

• Brand Name: CARDINAL HEALTH
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 23742947
• Report Number: 1423537-2025-00492
• Device Sequence Number: 8420817
• Product Code: KNT
• UDI-Device Identifier: 10192253011715
• UDI-Public: (01)10192253011715
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K833621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/30/2025

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: 8884720858E
• Device Catalogue Number: 8884720858E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 12/10/2025; 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Male