MAUDE Adverse Event Report: COVIDIEN SALEM SUMP DUAL LUMEN STOMACH TUBE W/ MULTI-FUNCTIONAL PORT WITH ENFIT; TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

Lot Number PT00030482

Device Problem Suction Problem (2170)

Patient Problem Vomiting (2144)

Event Date 06/17/2019

Event Type  malfunction  

Event Description

Patient had enfit ngtube placed for tube feedings while intubated and sedated in icu.Patient then starting having coffee ground emesis so nasogastric tube (ngt) placed to wall suction, only a limited amount came out.Rn's were attempting to trouble shoot but patient then vomited again around the nasogastric (ng) tube.

• Brand Name: SALEM SUMP DUAL LUMEN STOMACH TUBE W/ MULTI-FUNCTIONAL PORT WITH ENFIT
• Type of Device: TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8730751
• MDR Text Key: 149084991
• Report Number: 8730751
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/19/2019,06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: PT00030482
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Weight: 103