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 Codes	Anxiety (2328); Discomfort (2330)
Date of Event	01/16/2026
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 this product has been breaking off at the white half with the perforated holes.This leaves the blue half lodged in the ng.This half is almost impossible to remove unless manipulated with the use of large pliers and scissors, which they were able to do for this patient.This did cause stress and unnecessary discomfort to the patient.This is not the first time this product has broke while in use with a patient and it always breaks at that same spot.
Additional Manufacturer Narrative
A device was not returned for evaluation; therefore, the affected product could not be evaluated to confirm the reported failure mode.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 walk was held in the production area to review the manufacturing process, and it was concluded that the current manufacturing activities are running according to product specifications meeting quality acceptance criteria, validation processes, and release procedures.Based on all available information, a root cause could not be determined at this time.A corrective and preventative action has been initiated to further investigate and address 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: 24274966
• Report Number: 1423537-2026-00028
• Device Sequence Number: 18822967
• Product Code: KNT
• UDI-Device Identifier: 10884527022762
• UDI-Public: (01)10884527022762(17)300731(10)2522700864
• 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): 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: 2522700864
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown