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

Model Number	8884721055E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/04/2025
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 ngt was inserted in ivr on (b)(6) and was removed today to find a ruptured looking tube with the distal weighted portion missing.They are waiting on a plan for the patient to determine whether the patient will have a scope or wait and pass.Possible lot number: 2519801064.Per additional information provided on december 15th, 2025, gastroenterology performed an esophagogastroduodenoscopy on (b)(6) but the ng tip had migrated beyond reach.Serial x-rays and stool charting were completed to monitor the progression of the ng tip.The foreign body was removed via colonoscopy on (b)(6) without complication.
Additional Manufacturer Narrative
The device history record (dhr) could not be reviewed as no lot information was provided within the complaint.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 device was not returned for evaluation; therefore, the affected product could not be evaluated to confirm the reported failure mode.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 reported condition.Based on all available information, a root cause could not be determined at this time.We will continue to monitor related reports to determine if additional actions are necessary.

• 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: 23816497
• Report Number: 1423537-2025-00505
• Device Sequence Number: 10067057
• Product Code: KNT
• UDI-Device Identifier: 10192253011739
• UDI-Public: (01)10192253011739
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K833621
• 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
• Report Date (Section B): 02/02/2026

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: 8884721055E
• Device Catalogue Number: 8884721055E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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