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

Model Number	8884721252E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/17/2026
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 a patient was admitted on neuro unit who came to mdc endo for peg tube placement.When nurses from neuro removed his ng feeding tube, part of it must have broke off and stayed in the patient's stomach.The nurse who removed it was unaware that the tube had broken off and was left in the patient.When the doctor did an endoscopy to insert the new peg tube, he found the small piece of the ng feeding tube that broke off and removed it from patient's stomach.In the part of the tube that was left inside the patient, it looks like little medication beads were plugging the tube.On (b)(6) 2026, the customer confirmed that the portion of the tube that remained in the patient was removed via the endoscopy performed to place the peg tube, no further surgeries/procedures were performed.
Event or Problem Description
The customer reported a patient was admitted on neuro unit who came to mdc endo for peg tube placement.When nurses from neuro removed his ng feeding tube, part of it must have broke off and stayed in the patient's stomach.The nurse who removed it was unaware that the tube had broken off and was left in the patient.When the doctor did an endoscopy to insert the new peg tube, he found the small piece of the ng feeding tube that broke off and removed it from patient's stomach.In the part of the tube that was left inside the patient, it looks like little medication beads were plugging the tube.On 31mar2026, the customer confirmed that the portion of the tube that remained in the patient was removed via the endoscopy performed to place the peg tube, no further surgeries/procedures were performed.Per additional information provided on 13apr2026, the date of insertion is unknown.The nurse removed the tube on (b)(6) 2026.The physician discovered the remaining piece and removed it within 30-60 minutes of the tube being removed from the nare.The surgeon was placing a pg/peg tube, noted and removed the distal end of the tube.Regarding the mention of "little medication beads", the customer further stated the medication provided was flomax.Flushing was done per policy.There was no harm to the patient.The patient was transferred to rehab on (b)(6) stable.
Additional Manufacturer Narrative
A non-conformance/device history record review could not be conducted because a lot number was not provided.Therefore, a review of the specific manufacturing and inspection records was not possible.However, all product lots are required to meet established acceptance criteria and must successfully pass defined visual and functional inspections prior to release.A gemba walk was held in the production area.As a result, it was concluded that the current manufacturing activities are running according to product specifications meeting quality acceptance criteria, validation process and released procedures.No conditions were found that could trigger the reported condition.One sample was received in a used condition without the original packaging for investigation.The device was evaluated and the reported condition was observed; a break was detected near the number 20 where a balloon shape had also formed.Evaluation of the damaged section was conducted.Medication residue was identified within the tubing, resulting in an internal blockage.This blockage likely caused increased pressure during use, leading to tube expansion (ballooning) and a subsequent burst.The potential root cause of the reported condition could be related to inadequate compliance with the product instructions.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: 24753643
• Report Number: 1423537-2026-00091
• Device Sequence Number: 21422597
• Product Code: KNT
• UDI-Device Identifier: 10192253011838
• UDI-Public: (01)10192253011838
• 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,Followup
• Report Date (Section B): 06/17/2026

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
• Operator of Device: Health Professional
• Device Model Number: 8884721252E
• Device Catalogue Number: 8884721252E
• 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: 03/25/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 04/14/2026; 06/17/2026
• 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
• Patient Sex: Unknown