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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Low Blood Pressure/ Hypotension (1914); Pneumonia (2011); Tachycardia (2095)
Date of Event	08/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported at 2100h the writer went to check the patient with the night dose of medication and the patient was found to have a lot of sputum around her mouth and she was semi responsive.The writer did oral suction and checked the patients' vital signs.The rapid response team was initiated.Patient's gcs decreased to 12.Patient's blood pressure was 79/30mmhg, heart rate was 166, temperature was 39.7.Tympanic.Dr.(b)(6) was informed about the patient's health status.At 2110h the patient was handed over to the rapid response team.Dr.(b)(6) arrived at 2140h.Ecg, chest x-ray, blood test, iv lines, vasopressors, medication, and a foley catheter was inserted by rapid response team.After intervention and treatment, md decided to send the patient to the icu.Based on all available information, there is no allegation of a product malfunction at this time.Multiple good faith efforts have been made to request additional information from the reporter.However, to date a response has not yet been received.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion the results will be forwarded.
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.As part of the investigation all processes and controls were reviewed and found to be correctly followed.There were no abnormal conditions found that could trigger the reported event.The device was not returned for evaluation; therefore, the affected product could not be evaluated.Based on all available information, we are unable to determine the relationship between the device and cause of the reported event.We will continue to monitor related reports to determine if additional actions are necessary.

• 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: 23995577
• Report Number: 1423537-2026-00003
• Device Sequence Number: 10531247
• Product Code: FEG
• UDI-Device Identifier: 10192253012804
• UDI-Public: (01)10192253012804(10)2428510064
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K190923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 8888266122
• Device Catalogue Number: 8888266122
• Device Lot Number: 2428510064
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 01/07/2026; 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female