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

Model Number	8884711253E
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported the guidewire of a feeding tube was not removed after insertion.The port and the guidewire look alike and are the same color making differentiation difficult for an inexperienced clinician to determine the difference.Per additional information received on november 05, 2025, there was no specific injury that resulted to the patient but this event met their reportability requirement under unintentional retained foreign item.When they refer to a retained foreign item, they are referring to the stylet that was left inside the ng tube that was inserted into the patient only.The enteral feeding tube was removed entirely but not replaced as the family finally agreed on peg tube insertion which was done 3 days after the retained foreign item discovery.The patient was sent back to the ed because of the tube feeding malfunction on (b)(6) 2025, the peg tube was inserted on (b)(6) 2025, and they were discharged (b)(6) 2025.Per further information provided on (b)(6) 2025, the patient presented to (b)(6) on (b)(6) 2025 from the (b)(6) due to the feeding tube being pulled out by patient and was replaced.He was discharged back on (b)(6) 2025 to (b)(6).The patient was readmitted on (b)(6) 2025 due to tube feeding malfunction and it was discovered that the guidewire was still present after 4 days of use in the (b)(6).The guidewire was left in for 4 days, then it was not usable anymore hence him being sent back to the ed.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion the results will be forwarded.
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 device was not returned for evaluation; therefore, the affected product could not be evaluated.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: 23586264
• Report Number: 1423537-2025-00463
• Device Sequence Number: 21126732
• Product Code: KNT
• UDI-Device Identifier: 10192253011296
• UDI-Public: (01)10192253011296(17)300630(10)2518800164.
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/19/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 8884711253E
• Device Catalogue Number: 8884711253E
• Device Lot Number: 2518800164
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Race: Asian