MAUDE Adverse Event Report: CARDINAL HEALTH, INC. 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)
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 that the anti reflux cap has broken in half.Per customer, the nurse was with the patient in bed during the incident, the patient did not know why the cap had broken in half.The issue was detected during the commissioning of the product; this has had no consequences for the patient involved.
Additional Manufacturer Narrative
Section d4: lot number, expiration date and unique identifier (udi) # has been added.
Additional Manufacturer Narrative
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.One representative sample was received for investigation.The device was inspected, and the reported condition was observed.Based on all available information a definitive root cause could not be determined at this time.A corrective and preventative action has been opened to address the reported condition.We will continue to monitor related reports to determine if additional actions are needed.

• 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: 22430825
• Report Number: 1423537-2025-00278
• Device Sequence Number: 3163346
• Product Code: KNT
• UDI-Device Identifier: 10884527022762
• UDI-Public: (01)10884527022762(17)290831(10)2426102364
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 08/29/2025

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: 266197
• Device Catalogue Number: 266197
• Device Lot Number: 2426102364
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 07/08/2025; 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown