MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CATHETER MOUNT DOUBLE SWIVEL CONNECTOR; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/594/000

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device evaluation in progress.

Event Description

It was reported that upon the use of the product for a patient, the customer noticed that an air leak alarm was issued from the artificial respirator.So, they pressed the lid for the catheter mount's suction port with hand and the situation was remedied.They then replaced the product with a new one, and since then, no air leak has been observed.No death or serious injury was reported in connection with this incident.

Manufacturer Narrative

One used sample was returned for analysis.Inspection procedure for the connectors.Family, leakage and blockage test for connectors and manufactura de los connectors.Procedures were reviewed and deemed adequate.The red ball test was performed.The returned sample revealed that the red ball was floating before rotation and when the fixture is rotated the manometer red ball was moved over 3ml/min mark; indicating a leak since it was over 3ml/min.While submerged under water, 10 pounds per square inch (psi) of air pressure was applied to the sample revealing a small stream of bubbles at the union of the swivel connector and the adaptor bushing.A history review was performed observing that the non-conformity (b)(4) was issued to the part number 005/080/021 due to it was observed that the dimensions were out of specification.Dimensions were inspected and found acceptable.Based on the evidence, the complaint was confirmed and the root cause is related to a supplier issue.

• Brand Name: CATHETER MOUNT DOUBLE SWIVEL CONNECTOR
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7895722
• MDR Text Key: 120966742
• Report Number: 3012307300-2018-04026
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 100/594/000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Date Manufacturer Received: 10/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1