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

Model Number 8888266148

Patient Problems Aspiration/Inhalation (1725); Discomfort (2330)

Event Date 08/26/2023

Event Type  malfunction  

Event Description

The incident in question involved a patient who had an ng (nasogastric) tube placed for medical reasons.A small bowel follow-through (sbft) test was scheduled for the morning, requiring the ng tube to be temporarily clamped.To achieve this, the blue/white filter was inserted into the open end of the ng tube as a plug.However, when it was time to reconnect the patient to wall suction, the filter broke in half and became lodged inside the ng tube.Efforts were made by both a registered nurse (rn) and the charge nurse to remove the stuck filter, but these attempts were unsuccessful.Multiple tools were employed in the attempt to dislodge the filter, but they proved ineffective.Since the ng tube was rendered nonfunctional due to this problem, it was decided to remove it with the intention of replacing it with a new, functional ng tube.Four attempts were made to replace the ng tube.Unfortunately, during one of these attempts, the patient aspirated water and attempts were unsuccessful.Due to the complications arising from the malfunction of the ng tube and the failure of the vent cap, the patient had to be transferred to another healthcare facility for more specialized care and placement of a new ng tube.This incident led unnecessary discomfort for the patient and the need for a transfer, which could have been prevented if the product had not become stuck and broken during its use.

• Brand Name: SALEM SUMP
• Type of Device: TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 18029642
• MDR Text Key: 326852899
• Report Number: 18029642
• Device Sequence Number: 1
• Product Code: FEG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888266148
• Device Catalogue Number: 8888266148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28470 DA