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

Model Number 8888266148

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2018

Event Type  malfunction  

Event Description

The salem pump valve separated while in use.No harm.

Manufacturer Narrative

The following elements have blank data.

Event Description

The salem pump valve separated while in use.No harm.

• Brand Name: SALEM SUMP
• Type of Device: TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): COVIDIEN LP; 710 medtronic parkway; minneapolis MN 55432 5604
• MDR Report Key: 7333618
• MDR Text Key: 102249317
• Report Number: 7333618
• Device Sequence Number: 1
• Product Code: FEG
• UDI-Device Identifier: 10884521004726
• UDI-Public: (01)10884521004726
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888266148
• Device Catalogue Number: 8888266148
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/09/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1