MAUDE Adverse Event Report: COVIDIEN ARG SALEM SUMP TB W/ARV 16FR STRL; SALEM SUMP TUBE

Model Number 8888266130

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to covidien that a customer had an issue with a salem sump tube.The customer states that the tube was leaking from the insertion site of the blue one way valve tubing into the clear tubing.There was no injury to the patient.The faulty ng tube was removed and a new one was placed.

Manufacturer Narrative

Samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.Based on the information available, a corrective and preventive action (capa) is not necessary at this time.This information will be utilized for trending purposes to determine the need for corrective actions.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.If the sample is received, the complaint will be reopened for investigation.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARG SALEM SUMP TB W/ARV 16FR STRL
• Type of Device: SALEM SUMP TUBE
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6057298
• MDR Text Key: 58844964
• Report Number: 9612030-2016-00565
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888266130
• Device Catalogue Number: 8888266130
• Device Lot Number: 529504264X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1