MAUDE Adverse Event Report: CARDINAL HEALTH SALEM SUMP W/ ARV 18FR. 48IN; TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

Model Number	8888266148
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Septic Shock (2068); Perforation of Esophagus (2399); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h6: health effect - clinical code - 4581 appropriate term / code not available was used to capture mediastinitis.An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that while the item was being inserted into the patient's esophagus, a perforation occurred causing injury to the patient.The customer stated that they cannot be sure if the perforation was caused due to an issue with the item itself or if it was an error in executing the procedure using the product.Additional information provided on (b)(6), 2023 stated that the perforation was on the esophagus.As a result, the patient required surgery, a left thoracotomy with total pulmonary decortication and washout.Additionally, the patient had septic shock secondary to mediastinitis as a result of this incident.The patient's current status is stable.Additional information provided on (b)(6), 2023 stated that the patient originally went to the hospital for robotic assisted colostomy takedown.The initial reason for the salem sump placement was due to general anesthesia.The salem sump was placed in the or by a md and crna.
Additional Manufacturer Narrative
We have concluded our investigation process related to the reported complaint.Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.

• Brand Name: SALEM SUMP W/ ARV 18FR. 48IN
• Common Device Name: TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17393962
• Report Number: 9612030-2023-03769
• Device Sequence Number: 20322324
• Product Code: FEG
• UDI-Device Identifier: 10884521004726
• UDI-Public: 10884521004726
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2023

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
• Operator of Device: Health Professional
• Device Model Number: 8888266148
• Device Catalogue Number: 8888266148
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 10/13/2023
• 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 Age: 64 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Race: White