MAUDE Adverse Event Report: CARDINAL HEALTH, INC. COVIDIEN; 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	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a gastrostomy tube with a balloon defect was evident, which explains the accidental dislodgement.The stoma is healthy with slight gastric secretion through the stoma which is cleaned with saline solution.An 18mm catheter was passed to prevent closure of the stoma, it was verified that it was in the gastric cavity by means of auscultation by insufflation of 20 cc of air and gastric residue.The balloon was inflated with 10cc sterile water, it was connected to a collection bag.The attending physician was informed.Se evidencia sonda de gastrostomía con defecto en balón, lo cual explica la salida accidental, estoma sano, con leve secreción gástrica por estoma, la cual se limpia con solución salina, se realiza paso de sonda foley 18 para evitar cierre de estoma, se comprueba que se encuentra en cavidad gástrica por medio de auscultación de insuflación de 20 cc de aire y residuo gástrico, se insufla balón con 10 cc de agua estéril, y se conecta a bolsa recolectora.Se informa al médico tratante.A gastrostomy tube with a balloon defect is evident, which explains the accidental dislodgement, a healthy stoma, with slight gastric secretion through the stoma, which is cleaned with saline solution, a 18 mm foley catheter is passed to avoid closure of the stoma, it is verified that it is in the gastric cavity by means of auscultation by insufflation of 20 cc of air and gastric residue, the balloon is inflated with 10 cc of sterile water, and it is connected to a collection bag.The attending physician is informed.
Additional Manufacturer Narrative
A physical sample was not provided for investigation, but a video was received.The video was reviewed, and the reported condition was observed.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.Based on all available information a definitive root cause could not be determined at this time.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.

• Brand Name: COVIDIEN
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 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: 21573899
• Report Number: 1423537-2025-00122
• Device Sequence Number: 15637754
• Product Code: KNT
• UDI-Device Identifier: 10884521661721
• UDI-Public: (01)10884521661721(17)270601(10)2412709364
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 03/11/2025

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: 8884720221E
• Device Catalogue Number: 8884720221E
• Device Lot Number: 2412709364
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 03/11/2025
• Date Device Manufactured: 06/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown