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

Model Number	8884720825E
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Sore Throat (2396)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion the results will be forwarded.
Event or Problem Description
The customer reported they have significant problems removing the mandrel during each installation.This has resulted in treatment failures and complaints from families.They even tried removing the mandrel before installation, but this was not successful.According to the customer, the packaging does not include any information that would enable them to provide safe and effective care.The clinician nurse stated they put this kangaroo tubing in 2-3 times a year and it is usually applied by a gastroenterologist but according to their decision, it is now applied by the nurse.The last time was last week, on a child, two years old, around 10 kg.When the kangaroo tubing was inserted, it was impossible to remove the mandrel.During 48 hours, the child had not been fed through any tubing.The child has an iv drip to supply what was needed.After a few days, they put in a normal nasogastric tube.Nurses have also made a test with three samples, out of the patient, and it was not possible to remove the mandrel, except for from one tube only.Per additional information provided, the customer did not activate the hydromer prior to or after placement.The patient's digestive tract was irritated by the repeated insertion of the nasogastric feeding tube.There was no bleeding.No additional pain medication was administered because the child was already receiving heavy treatment that included painkillers.Medical decision by the healthcare team; the child was therefore given parenteral iv treatment.There was no other surgical or medical intervention.
Additional Manufacturer Narrative
A device was not returned for evaluation; therefore, the affected product could not be evaluated to confirm the reported failure mode.The device history record (dhr) could not be reviewed as no lot information was provided within the complaint.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.A gemba walk was performed to review the manufacturing process.As a result, it was concluded that the current manufacturing activities are running according to product specifications meeting quality acceptance criteria, validation process, and released procedures.The investigation was carried out with the multifunctional team, and all processes and controls were found to be followed correctly, including packaging and all inspections performed on the product.No conditions were found that could trigger the reported condition.The potential root cause indicates that the reported condition could occur due to improper use of the procedure if the instructions for use are not followed.We will continue to monitor related reports to determine if additional actions are necessary.

• 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: 24310512
• Report Number: 1423537-2026-00032
• Device Sequence Number: 17561808
• Product Code: KNT
• UDI-Device Identifier: 10192253011654
• UDI-Public: (01)10192253011654
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K833621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2026

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
• Operator of Device: Health Professional
• Device Model Number: 8884720825E
• Device Catalogue Number: 8884720825E
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/02/2026; 03/13/2026
• 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 Age: 24 MO
• Patient Sex: Male
• Patient Weight: 10 KG