MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC DOBBHOFF 12FR 43IN W STYLET EN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884711253E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Gastrointestinal Regurgitation (4477)
Date of Event	09/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion the results will be forwarded.
Event or Problem Description
The customer reported the patient was admitted on (b)(6) 2025 for elective surgery with a diagnosis of pancreatic head neoplasm, at witch time a nasogastric enteric tube was placed (dobbhof w/ 12fr enfit).On (b)(6) 2025, the patient presented with regurgitation of feeding through the feeding tube aspiration tube levin type.The sne was positioned in the jejunal loop when it ruptured, and through an endoscopic exam its distal end was removed.It was located in the proximal third, 19cm from the upper dental arch, past cricopharyngeus.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Prior to a lot¿s release, the lot must be deemed acceptable by-passing inspections that are based on a valid sampling plan.During production, inspectors routinely examine a statistical sample both physically and visually.A physical sample was not returned for investigation, but photos were provided.The photos were evaluated, and the reported condition was observed.As part of the investigation all processes and controls were reviewed and found to be correctly followed.There were no abnormal conditions found that could trigger the observed condition.Based on all available information, the root cause could not be determined at this time.We will continue to monitor related reports to determine if additional actions are necessary.
Event or Problem Description
The customer reported the patient was admitted on (b)(6) 2025 for elective surgery with a diagnosis of pancreatic head neoplasm, at witch time a nasogastric enteric tube was placed ( dobbhof w/ 12fr enfit ).On (b)(6) 2025, the patient presented with regurgitation of feeding through the feeding tube aspiration tube levin type.The sne was positioned in the jejunal loop when it ruptured, and through an endoscopic exam its distal end was removed.It was located in the proximal third, 19cm from the upper dental arch, past cricopharyngeus.Per additional information provided on (b)(6) 2025, the patient was using both types of tubes together, sne - dobbhoff/ levine in the stomach.

• Brand Name: DOBBHOFF 12FR 43IN W STYLET EN
• 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 IL 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 23311113
• Report Number: 1423537-2025-00412
• Device Sequence Number: 17592877
• Product Code: KNT
• UDI-Device Identifier: 10192253011296
• UDI-Public: (01)10192253011296
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884711253E
• Device Catalogue Number: 8884711253E
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 10/20/2025; 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 63 KG