MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

Model Number	8888266122E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the blue/white filtered plug end for ng tube pulled apart at the white end with white portion stuck in tube.Removed white portion with use of kelly clamp.Still able to utilize ng.Additional details about incident: when the filter/valve had been attempted to be removed from the tubing it had gotten stuck.Manual removal was unsuccessful and the white portion of the filter snapped off.The blue portion was able to be removed from the tubing with the assist of a kelly clamp.The ng tubing was unaffected and did not have to be replaced, only the filter/valve.
Additional Manufacturer Narrative
Additional product code: pif.A non-conformance review could not be performed because 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.The device was returned for evaluation; therefore, the affected product could not be evaluated to confirm the reported failure mode.As such, a root cause could not be determined.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: CARDINAL HEALTH
• Common Device Name: TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• 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: 21990404
• Report Number: 1423537-2025-00197
• Device Sequence Number: 8312716
• Product Code: FEG
• UDI-Device Identifier: 10192253012811
• UDI-Public: (01)10192253012811
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K190923
• 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
• Report Date (Section B): 05/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8888266122E
• Device Catalogue Number: 8888266122E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 05/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown