MAUDE Adverse Event Report: CARDINAL HEALTH, INC. COVIDIEN; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	8884720247E
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported their client told them that the gastrostomy tube balloon deflates and the balloon has to be filled constantly.The food comes out on several occasions as a result of what happened.Per additional information received, the affected g-tube was replaced with a new one to resolve the issue.As reported: solicito de su apoyo de urgencia, ya que cliente nos comento que de la sonda de gastrostomía de código 8884720247e el globo se desinfla y se tiene que estar llenando el globo constantemente.La comida se sale en varias ocasiones por consecuencia de lo sucedido.English translation: i request your emergency support, since the client told us that from the gastrostomy tube code 8884720247e the balloon deflates and the balloon has to be filled constantly.The food comes out on several occasions as a result of what happened.
Additional Manufacturer Narrative
Additional product code: knt.An investigation is currently underway.Upon completion the results will be forwarded.

• Brand Name: COVIDIEN
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• 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 IL 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 24895826
• Report Number: 1423537-2026-00111
• Device Sequence Number: 18459529
• Product Code: PIF
• UDI-Device Identifier: 10884521661738
• UDI-Public: (01)10884521661738(17)270601(10)2411010564
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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: 8884720247E
• Device Catalogue Number: 8884720247E
• Device Lot Number: 2411010564
• 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: 04/13/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown