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 11/16/2016

Event Type  malfunction  

Event Description

The device separated into two pieces.

• Brand Name: SALEM SUMP
• Type of Device: TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): COVIDIEN LP; sona manickam; 15 hampshire st.; mansfield MA 02048
• MDR Report Key: 6137627
• MDR Text Key: 61205693
• Report Number: 6137627
• 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: 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Model Number: 8888266130
• Device Catalogue Number: 8888266130
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/23/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 11/23/2016
• 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