MAUDE Adverse Event Report: Cardinal Health 200, LLC CARDINAL HEALTH; Tubes, Gastrointestinal (And Accessories)

Model Number	8884711253E
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	09/14/2026
Type of Reportable Event	Malfunction

• Brand Name: CARDINAL HEALTH
• Common Device Name: Tubes, Gastrointestinal (And Accessories)
• Manufacturer (Section D): Cardinal Health 200, LLC; 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 ; +1(508)316-3640
• MDR Report Key: 50820823
• Report Number: 1423537-2026-00295
• Device Sequence Number: 10201783
• Product Code: KNT
• UDI-Device Identifier: 10192253011296
• UDI-Public: (01)10192253011296(17)300731(10)2521801164
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K112511
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 8884711253E
• Device Catalogue Number: 8884711253E
• Device Lot Number: 2521801164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/18/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Female