MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC T-TUBE 19FR SILICONE; Catheter, Irrigation

Model Number	SU130-1334
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	08/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported that they had a patient within the last month who had to be brought back to surgery due to these tubes malfunctioning.The customer stated that the original surgery date with tube placement was (b)(6) 2026.Patient was taken to ir when the drain malfunctioned for tube injection with conscious sedation on (b)(6)2026.Patient was brought back to or for laparoscopic tube placement with general anesthesia.A different tube was placed during this case.Patient was discharged from the hospital on (b)(6) 2026 and stable.
Additional Manufacturer Narrative
An investigation is currently in progress.A follow-up report will be filed once the results have been completed.

• Brand Name: T-TUBE 19FR SILICONE
• Common Device Name: Catheter, Irrigation
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): PR006 PUERTO RICO-Anasco; state rd. 402 , north km 0.9; anasco PR 00610
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; +1(508)618-3640
• MDR Report Key: 50872255
• Report Number: 1423537-2026-00304
• Device Sequence Number: 15759081
• Product Code: GBX
• UDI-Device Identifier: 00192253022462
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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
• Operator of Device: Health Professional
• Device Model Number: SU130-1334
• Device Catalogue Number: SU130-1334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 09/23/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown