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

Model Number	8888266197
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.There were no devices returned for evaluation; therefore, the affected product 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 that the patient has nasogastric tube to low-intermittent suction.Patient's ng tube was clamped following liquid po tylenol administration.Ng tube was clamped using "salem sump anti-reflux valve" piece.When disconnecting piece from ng tube to return to suction, white part of "salem sump anti-reflux valve" broke and became lodged into ng tube, completely blocking tube.Piece was able to be removed after 15min of attempting to dislodge piece.Ng returned to lis without any further issue following removal.

• Brand Name: SALEM SUMP
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 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: 22812398
• Report Number: 1423537-2025-00324
• Device Sequence Number: 8756592
• Product Code: KNT
• UDI-Device Identifier: 10884521007628
• UDI-Public: (01)10884521007628
• 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
• Report Date (Section B): 08/14/2025

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: 8888266197
• Device Catalogue Number: 8888266197
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 08/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown