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

Model Number	8884720221E
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported they have recently observed an increased incidence of balloon rupture resulting in tube dislodgement.The current incident occurred on february 28th before the start of feeding at 1600hr.The device came out and it was found that the balloon had already ruptured.It was replaced with another g-tube of the same item code.
Additional Manufacturer Narrative
Additional product code: pif an investigation is currently underway.Upon completion the results will be forwarded.
Additional Manufacturer Narrative
The device was not received for investigation, but a photo was provided.The photo was reviewed and the reported condition was observed.The device history record 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 on-site inspection of the manufacturing process was performed and it was determined that the current process and controls were being followed correctly, including sub-assemblies, finished product assembly, packaging, and product inspections.No abnormal conditions were found that could continue to trigger the reported condition.A supplier corrective action request has been opened with the supplier to address the reported condition through a more thorough investigation.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: 24584830
• Report Number: 1423537-2026-00069
• Device Sequence Number: 9158174
• Product Code: KNT
• UDI-Device Identifier: 10192253068818
• UDI-Public: (01)10192253068818
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K180622
• 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
• Report Date (Section B): 04/20/2026

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
• Device Model Number: 8884720221E
• Device Catalogue Number: 8884720221E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/20/2026
• 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 Sex: Unknown