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

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 when trying to fill the balloon with 15cc of sterile water, it was found to have a leak.
Additional Manufacturer Narrative
Additional product code: pif.An investigation is currently underway.Upon completion the results will be forwarded.
Additional Manufacturer Narrative
In addition to videos and a photo, one device was received for investigation.All materials provided were evaluated and the reported condition was observed.The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the issue described by the customer.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Additionally, no non-conformances were opened during manufacturing process.The device was manufactured on february 13, 2025.As part of the investigation, a gemba inspection was performed to review the manufacturing process.It was determined that the current process and controls are being followed and functioning correctly, including subassemblies, 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 sent to the supplier to further investigate and address the reported issue.In addition, staff have been notified of this complaint to raise staff awareness.We will continue to monitor the process, customer complaints, and feedback notifications to detect any adverse trends and 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: 24445270
• Report Number: 1423537-2026-00044
• Device Sequence Number: 10212527
• Product Code: KNT
• UDI-Device Identifier: 10884521661738
• UDI-Public: (01)10884521661738(17)270901(10)2504205164
• Combination Product (Y/N): N
• Initial Reporter Country: GT
• PMA/510(K) Number: K180622
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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: 2504205164
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown