MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC SALEM SUMP; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	7771810E
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Nasogastric (ng) tube was placed in patient in the emergency department (ed), and patient was transferred to the 6th floor.The registered nurse (rn) received orders to place contrast down the ng tube.When the rn tried to put the contrast down the ng tube, it was leaking from the hard plastic piece and from the area around the air vent where it attaches to the main tube.Ng tube was removed and replaced with another ng tube.No known harm to the patient at this time.

• Brand Name: SALEM SUMP
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 20662657
• Report Number: 20662657
• Device Sequence Number: 8502961
• Product Code: PIF
• UDI-Device Identifier: 10192253010435
• UDI-Public: (01)10192253010435
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/03/2024
• Report Date (Section F): 10/03/2024

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: 7771810E
• Device Catalogue Number: 7771810E
• Device Lot Number: 2405900564
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 11/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/03/2024