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	05/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the writer went to unclamp the salem sump nasogastric tube (ng) as it had been 30 minutes since the administration of medication.Per customer, the anti-reflux valve broke off inside the distal end of the salem sump.The writer and another nurse attempted to remove it by hand and with a clamp, but the broken end kept breaking off small pieces of the plastic.The writer was able to cut the distal portion off, preserving the tube and its function and reconnect the patient to low continuous suction.There was no patient harm reported.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record review could not be performed since no lot number was provided.A picture was provided for evaluation.Upon reviewing the picture, the white part of the broken valve could be seen, however the broken part was inserted into a tube that was not part of the device.It was also observed that the broken part was manipulated (excessive force).A physical device was not returned for evaluation.A definitive root cause could not be determined.Based on this information, no corrective actions are warranted at this time.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, 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: 22107640
• Report Number: 1423537-2025-00216
• Device Sequence Number: 18177824
• 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,Followup
• Report Date (Section B): 06/20/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 06/20/2025
• 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