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

Model Number	8884720205E
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a balloon test was performed with 20ml of distilled water and the balloon showed damage.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) for lot number 2401902164 was reviewed and no anomalies related to the reported issue were observed.A sample was not received for the investigation.Because a sample was not returned, we were unable to perform a follow-up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.However, as a part of continuous improvements, a supplier corrective action request (scar) has been issued to the supplier to address the reported condition through a more robust investigation and results of the investigation will be documented through the referred capa.

• 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: 22180839
• Report Number: 1423537-2025-00237
• Device Sequence Number: 20933105
• Product Code: KNT
• UDI-Device Identifier: 10884521661714
• UDI-Public: (01)10884521661714(17)270301(10)2401902164
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 07/11/2025

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: 8884720205E
• Device Catalogue Number: 8884720205E
• Device Lot Number: 2401902164
• 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: 05/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/11/2025
• 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