MAUDE Adverse Event Report: CARDINAL HEALTH TUBE SALEM SUMP SIL 5IN1 16FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8888265132
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/03/2023
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 that the salem sump was removed from the patient with the distal end missing.None present in mouth to suggest patient biting.52cm missing.Additional information received on 30aug2023 stated that the missing piece was not located nor removed as the patient died due to unrelated issues.
Additional Manufacturer Narrative
The device history record review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.One used sample was received for evaluation.A visual inspection was performed; it was noticed that there was at least 20" of the catheter missing.A cut or break in the catheter was also noticed.However based on the available information the root cause could not be confirmed as being related to the manufacturing/production process as it was reported the product was used in a procedure and not as an out of box failure.This complaint will be used for tracking and trending purposes.

• Brand Name: TUBE SALEM SUMP SIL 5IN1 16FR
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17720953
• Report Number: 1282497-2023-10789
• Device Sequence Number: 15257253
• Product Code: KNT
• UDI-Device Identifier: 10884521020092
• UDI-Public: 10884521020092
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 01/02/2024

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: 8888265132
• Device Catalogue Number: 8888265132
• Device Lot Number: 223600009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown