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

Model Number	8884710826E
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Hemoptysis (1887); Hemorrhage/Blood Loss/Bleeding (1888); Hypoxia (1918); Septic Shock (2068)
Type of Reportable Event	Serious Injury
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.There were no samples returned for evaluation, therefore the affected device could not be evaluated to confirm the reported failure.As such, a root cause could not be determined.We will continue to monitor related reports to determine if additional actions are necessary.
Event or Problem Description
The customer reported a case of extreme difficultly removing the dobbhoff tube wire with the tube in the appropriate position.It was confirmed that the tube was flushed and the wire was moving freely before insertion.Confirmed proper placement on xray with no indication of any sharp turns/kinks which would hinder wire removal.When the wire was attempted to be removed, it required extreme force.The team removed the tube before trying to use force to remove the wire and had the same difficultly with 3 different tubes requiring 3 different sets of xrays and ultimately leading to the patient having blood secretions/aspirations likely from trauma due to prolonged attempted insertion.Ultimately, they obtained a 4th tube from another unit and had success.Additional information received on 23jul2025 stated that the patient ended up having hemoptysis and aspiration with hypoxia requiring transfer to icu.Patient received inhaled txa, had ent pull out clot.The patient ended up needing to be intubated (though she also had issues with mental status and aspirated a tooth which was unrelated).Ultimately, she ended up in septic shock.She did not require nasal packing, but did continue to have bloody secretions.

• 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: 22772713
• Report Number: 1423537-2025-00316
• Device Sequence Number: 9167253
• Product Code: KNT
• UDI-Device Identifier: 10192253011159
• UDI-Public: (01)10192253011159
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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 Practitioner
• Type of Report: Initial
• Report Date (Section B): 08/11/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8884710826E
• Device Catalogue Number: 8884710826E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 08/11/2025
• 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: Female