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	09/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records (dhr) for the finished good identified no manufacturing issues associated with lot 1231518 that could correlate with the reported condition.Lot 1231518 was manufactured on 30-nov-2023.Visual inspections performed on the drains within this lot met the established acceptance criteria.Further investigation was not possible because the customer did not provide the requested supporting documentation, including visual evidence of the reported condition, or a sample for evaluation.Ongoing monitoring activities are routinely performed to identify potential trends to support the continued safety, quality, and performance of cardinal health products.

• 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: 50847950
• Report Number: 1423537-2026-00301
• Device Sequence Number: 15827139
• Product Code: GBX
• UDI-Device Identifier: 00192253022462
• UDI-Public: (01)00192253022462(17)281130(10)1231518
• 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): 09/21/2026

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
• Device Lot Number: 1231518
• 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: 09/06/2026
• Initial Report FDA Received Date: 09/21/2026
• 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