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

Model Number	8888266197
Medical Device Problem Codes	Break (1069); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion the results will be forwarded.
Event or Problem Description
The customer reported the concern is that the anti-reflux valve easily breaks or becomes lodged in the ng tube.Per the customer, if it gets stuck in the tube, the contents from the broken valve could potentially enter the patient's stomach.It has occurred on their unit several times where it breaks.Per additional information provided on march 06, 2026 the issue is occurring during patient use.There have been occasions when nursing staff attempted to remove the arv, and it broke off inside the tube.In some cases, the entire tube had to be replaced.Other times the arv was removed, but it required significant force.They aren't able to provide specific details of each incident that has occurred as they were not documented, it was only mentioned to them during their staff huddle.
Additional Manufacturer Narrative
One unused and unopened representative sample of item code (b)(4), lot number 2513305164, was received for investigation.A non-conformance (nc) review was conducted for lot 2513305164 and there were no ncs related to the reported event issued during manufacturing.The representative device was functionally tested, and the reported conditions were not detected.A gemba walk was held in the production area.All processes were reviewed and it was verified that all processes and controls were carried out correctly, including packaging and all inspections carried out on the product.No abnormal conditions were found that could trigger the reported condition.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: SALEM SUMP
• 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: 24545142
• Report Number: 1423537-2026-00057
• Device Sequence Number: 9194099
• Product Code: KNT
• UDI-Device Identifier: 10192253012866
• UDI-Public: (01)10192253012866
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K851444
• 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): 04/17/2026

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: 8888266197
• Device Catalogue Number: 8888266197
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/17/2026
• 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