MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884711253E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported a dobhoff was placed for a critical patient in icu.The dobhoff became occluded, which does occur from time to time.Staff did the protocol to unclog the tube with the enzyme (pancrelippase 12,000u in a 0.4% sodium bicarb).This enzyme is part of the tube feeding order set.This enzyme unclogged the dobhoff for around 2 hours.2 hours later the tube was clogged again so staff decided to pull the tube and to replace with a new one per physician order.It was an easy pull out, however when they pulled the tube, they noticed the end of the tube was missing.Upon x-ray, it was observed that the end of the dobhoff remained in the stomach.This patient then had to have a procedure to remove the end that was remaining in the stomach.Per additional information provided on june 09, 2026, the feeding tube was in place for 12 hours before the occlusion alarm occurred.There were alarms for dislodged tube throughout half of the morning.The placement was routine, the stylet removal was uneventful, and placement was confirmed via x-ray.The tube was not repositioned after placement nor was the stylet ever reinserted.Other than the enzyme used, coke and warm water were also used as an unclogging method.The patient was intermittently confused and did pull on the tube but a bridle was in place.Another feeding tube was placed prior to the removal of the affected tube.There was no resistance during removal.The portion of the tube that remained in the patient's stomach was removed via esophagogastroduodenoscopy.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion the results will be forwarded.

• 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 ; 5086183640
• MDR Report Key: 25461822
• Report Number: 1423537-2026-00183
• Device Sequence Number: 8709079
• Product Code: KNT
• UDI-Device Identifier: 10192253011296
• UDI-Public: (01)10192253011296(17)300731(10)2522309164
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K112511
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2026

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
• Device Lot Number: 2522309164
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2026
• Supplement Report FDA Received Date: 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2025
• 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 Sex: Unknown