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

Model Number 8888266122

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/06/2018

Event Type  malfunction  

Event Description

Ng tube already placed in patient had the blue/white vent piece break in half twice.Ng tube blue section was able to be cut and replaced blue/white vent from a new package.The second time it broke, the clear tubing was able to be cut to place patient on low intermittent suction.

• Brand Name: SALEM SUMP
• Type of Device: TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 7897237
• MDR Text Key: 121036500
• Report Number: 7897237
• 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: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888266122
• Device Catalogue Number: 8888266122
• Device Lot Number: 1733219064
• 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: 09/19/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21900 DA