MAUDE Adverse Event Report: COVIDIEN ARG SIL SALEM SUMP TB 16FR STRL; SALEM SUMP TUBE

Model Number 8888265132

Device Problem Partial Blockage (1065)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a salem sump tube.The customer reports they are finding the silicone salem sumps are blocking frequently when they instill meds so they have to take them out and put in new ones as they will not unblock.Having to replace salem sump ng tubes is invasive for their patients, who are already in distress, since it is an icu.They had one patient who was in so much pain and they had to replace his salem sump more than once.Another tube was used as a result.The replacement was so painful to the patient that he had to be sedated.Their hospital stay was not extended and the patient was not harmed.

Manufacturer Narrative

Upon further review, this report was inadvertently created.This is a duplicate report of report 1282497-2016-00514.

• Brand Name: ARG SIL SALEM SUMP TB 16FR STRL
• Type of Device: SALEM SUMP TUBE
• Manufacturer (Section D): COVIDIEN; 37 blvd. insurgentes libriamento; a la p, la mesa; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; 37 blvd. insurgentes libriamento; a la p, la mesa; tijuana ; MX
• Manufacturer Contact: matthew amaral ; 15 hampshire street; mansfield, MA 02048 ; 2034926373
• MDR Report Key: 5808389
• MDR Text Key: 50754153
• Report Number: 1282497-2016-00517
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888265132
• Device Catalogue Number: 8888265132
• Device Lot Number: 153520284X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1