MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® SUCTIONAID TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/515/075

Device Problems Air Leak (1008); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

This device is same and/or similar to a device approved for distribution in the us.

Event Description

It was reported that a portex® suctionaid tracheostomy tube encountered a tear in the cuff and an air leak occurred.The leak occurred during patient use.An unplanned tracheostomy tube change was performed.No permanent injury was reported.

Manufacturer Narrative

Three smiths medical portex® suctionaid tracheostomy tubes were returned for analysis in used conditions.Upon visual exam, no holes were noted.A syringe was used to inflate the cuff of the sample and was submerged under water verifying that a leak was detected in the cuff.Relevant documents were reviewed and deemed adequate.The manufacturing process was conducted.Operations were reviewed with no discrepancies found: cuff assembly operation was reviewed; inflation line assembly operation was reviewed.Inflation test was audited during thirty two ((b)(4)) units revealing no deflated cuffs.A capa was opened to help determine the root cause and implement corrective actions.

• Brand Name: PORTEX® SUCTIONAID TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7304695
• MDR Text Key: 101230922
• Report Number: 3012307300-2018-00394
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/08/2022
• Device Catalogue Number: 100/515/075
• Device Lot Number: 3458504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention