MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC SALEM SUMP; TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

Model Number	8888266122
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Anxiety (2328)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during an attempt to remove the plug from the ng tube in order to reconnect it to suction, the plug broke and became stuck inside the tube.As a result, the ng tube could not be reconnected to suction.Attempts were made to remove the broken plug; however, the pieces came out in fragments and part of the plug remained lodged inside the tube.The tube was therefore unable to be used for suction.Further assistance was required to address the issue.The customer stated that the plug that comes with the tubing appeared to be the issue.They also have separate plugs available, and when they used one of those, it detached easily without any problems.Additional information received on 13may2026 confirmed that the issue was with the arv valve.They cannot confirm the reported lot number as the staff provided the numbers that they had at the time.They didn¿t have to insert another tube, but the patient was quite anxious when they initially couldn¿t remove it.Staff assisted by applying counter pressure while two people attempted to remove it, but it wouldn¿t budge.They then called another person in to stabilize the tube at the patient¿s nose to ensure they didn¿t accidentally dislodge it.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion the results will be forwarded.

• Brand Name: SALEM SUMP
• Common Device Name: TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• 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: 25173032
• Report Number: 1423537-2026-00156
• Device Sequence Number: 10566328
• Product Code: FEG
• UDI-Device Identifier: 10192253012804
• UDI-Public: (01)10192253012804
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K880850
• 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): 07/02/2026

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
• Operator of Device: Health Professional
• Device Model Number: 8888266122
• Device Catalogue Number: 8888266122
• Device Lot Number: 2525416364
• 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: 05/11/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2026
• Supplement Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown