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 Date 06/28/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 07/20/2016.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.

Manufacturer Narrative

Submit date: 09/19/2016.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.There were no samples received for evaluation.Because a sample was not available for evaluation, a root cause analysis could not be conducted to determine the root cause of this reported issue.If samples are received at a later date, this complaint will be re-opened and the investigation continued.A corrective action is not required at this time.This complaint will be used for tracking and trending purposes.

• 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: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5808337
• MDR Text Key: 50753391
• Report Number: 1282497-2016-00514
• 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

• 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
• Initial Date Manufacturer Received: 07/11/2016
• Initial Date FDA Received: 07/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1