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

Model Number 8888266130

Device Problem Material Separation (1562)

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

Event Date 06/05/2017

Event Type  malfunction  

Event Description

Device separated at blue tip.

• Brand Name: SALEM SUMP
• Type of Device: TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire st.; mansfield MA 02048
• MDR Report Key: 6659795
• MDR Text Key: 78156941
• Report Number: 6659795
• Device Sequence Number: 1
• Product Code: FEG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888266130
• Device Catalogue Number: 8888266130
• Device Lot Number: 703820964X
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/08/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NO OTHER THERAPIES