MAUDE Adverse Event Report: CARDINAL HEALTH, INC. COVIDIEN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884715122E
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code: pif.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.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 device was not returned for evaluation; therefore, the affected product could not be evaluated to confirm the reported failure mode.As such, a root cause could not be determined.However, a supplier corrective action request has been sent to the supplier to further investigate and address the reported condition.We will continue to monitor related reports to determine if additional actions are necessary.
Event or Problem Description
The customer reported complete displacement of the gastrostomy tube was evident.Upon discharge, the internal retention balloon was observed to be deflated, which could have facilitated its accidental dislodgement.The patient was taken to surgery with appropriate management and remains in the icu.

• Brand Name: COVIDIEN
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; 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: 23294551
• Report Number: 1423537-2025-00407
• Device Sequence Number: 21320318
• Product Code: KNT
• UDI-Device Identifier: 10884521661622
• UDI-Public: (01)10884521661622(17)270601(10)2414514964
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 10/14/2025

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: 8884715122E
• Device Catalogue Number: 8884715122E
• Device Lot Number: 2414514964
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 10/15/2025
• Date Device Manufactured: 06/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown