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

Model Number 8888266130

Device Problem Difficult to Remove (1528)

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

Event Date 05/04/2020

Event Type  malfunction  

Event Description

An emergency department patient had an ng tube placed.The patient was then admitted to the hospital.The ed nurse used the anti-reflux valve as a stopper in the tube during transport.When the patient arrived in the inpatient area, the nurse was unable to remove the anti-reflux valve from the ng tube in order to connect it to intermittent suction per provider orders.The tube had to be cut in order to remove the valve.We are suggesting an engineering change may be helpful in order for there to be a way to have a safe stopper in the tube itself instead of using the valve - or possibly modification of the valve so it can safety be used as a stopper for during patient transport and/or when not attached to suction.

• Brand Name: SALEM SUMP
• Type of Device: TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10100712
• MDR Text Key: 192666610
• Report Number: 10100712
• Device Sequence Number: 1
• Product Code: FEG
• UDI-Device Identifier: 10884521004719
• UDI-Public: (01)10884521004719
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888266130
• Device Catalogue Number: 8888266130
• Device Lot Number: 1921150964
• 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: 05/06/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24090 DA
• Patient Weight: 70