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

Model Number	266197
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
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 an ongoing issue with the spigot snapping on the white part when trying to remove from ng tube.
Event or Problem Description
The customer reported an ongoing issue with the spigot snapping on the white part when trying to remove from ng tube.Per additional information received on 11feb2026, the issue is generally occurring during patient use and is generally being resolved by removing with mosquito forceps.No further information is available.
Additional Manufacturer Narrative
The device was not returned for evaluation; however, a photograph was provided and the reported condition was observed.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.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.A gemba inspection was performed to review the manufacturing process, and it was determined that the process and current controls are being followed correctly, including subassemblies, final product assembly, packaging, and product inspections.Based on all available information, the root cause could not be determined at this time.A corrective and preventative action has been initiated to further investigate and address this 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: 24274952
• Report Number: 1423537-2026-00027
• Device Sequence Number: 21514206
• Product Code: KNT
• UDI-Device Identifier: 10884527022762
• UDI-Public: (01)10884527022762(17)290731(10)2422914464
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 02/25/2026

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: 266197
• Device Catalogue Number: 266197
• Device Lot Number: 2422914464
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 02/16/2026; 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown