MAUDE Adverse Event Report: CARDINAL HEALTH, INC. CARDINAL HEALTH; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884721252E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Pneumothorax (2012)
Date of Event	07/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that after a failed attempt to insert a naso-gastric (ng) feeding tube, a naso-enteric tube (ne, dobhoff) was inserted.After 30-minutes, the patient complained of difficulty breathing above her baseline.Additional information was received from the customer and stated that the patient was radiologically confirmed pneumothorax shortly after the attempted insertion and needed to be transferred to their icu for stabilization.The patient is alive but disabled on (b)(6) 2024, and has not had a follow-up in the muhc since.Per the customer, there is no further information regarding patient's disability and correlation with the dobhoff tube in the medical documentation from that appointment.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record review could not be performed since no lot number was provided.There were no samples returned for evaluation; therefore, the affected device could not be evaluated to confirm the reported issue.As such, a root cause could not be determined at this time.A definitive root cause could not be determined.Based on this information, no corrective actions are warranted 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, INC.; 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: 22197827
• Report Number: 1423537-2025-00247
• Device Sequence Number: 15887652
• Product Code: KNT
• UDI-Device Identifier: 10884521583030
• UDI-Public: (01)10884521583030
• 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): 07/15/2025

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
• Device Model Number: 8884721252E
• Device Catalogue Number: 8884721252E
• 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: 06/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/15/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Unknown