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

Model Number	266148
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 the gastric fluid was not drained, even if the measurement was correct.The reporter does not know if the person who inserted the tube changed the tube and saw a difference.For the return to surgery, it was noted when the valve had to be removed to flush the air intake, the valve broke in two.Per the nurse, the procedure was performed during a weekend in the emergency department between (b)(6) 2025.There was no consequence on the patient.Unfortunately, no more information is available regarding how the salem tube has been use or about the patient themself.Per additional information provided by the nurse on (b)(6) 2025, when they state "for the return to surgery" they are referring to the return of the catheter assessment by the nurse in the surgery department.The patient did not change locations of the hospital between the time the catheter was inserted and the time the valve broke.The catheter had been in place for 48 to 72 hours maximum.

• Brand Name: SALEM SUMP
• Common Device Name: TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• 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: 21343691
• Report Number: 1423537-2025-00069
• Device Sequence Number: 13012591
• Product Code: FEG
• UDI-Device Identifier: 10884521065055
• UDI-Public: (01)10884521065055(17)280731(10)2322309264
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 03/11/2025

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: 266148
• Device Catalogue Number: 266148
• Device Lot Number: 2322309264
• 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: 02/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown