MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD., PORTEX® CUFFED BLUE LINE SUCTIONAID TRACHEOSTOMY TUBE

Catalog Number 100/515/075

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Smiths medical has received the device sample.A full investigation is anticipated, but has not yet begun as the product sample is currently in transit to the investigation site.Once the device is evaluated, the manufacturer will file a follow-up report detailing the results.

Event Description

The user facility reported the tracheostomy tube was in use with a patient for 5 days when the inflation line became detached.The tracheostomy tube was replaced with a new one.The reporter indicated that no issues were observed with the device prior to patient use.No incident related medical sequela was reported.

Manufacturer Narrative

One used sample was returned for evaluation.Visual inspection confirmed the suction line detached/broke from the flange.Two samples of the same lot were taken from reserve and tested in attempt to replicate the reported event.Pull test was performed with no detachments found.Excessive force was then applied in attempt to replicate a similar break to the one of returned sample.The cut shape of the break that resulted when excess force applied is similar to the returned complaint sample.An excessive amount of stress on the suction line is the root cause of the reported event of breaking and separating from the connector.

• Brand Name: PORTEX® CUFFED BLUE LINE SUCTIONAID TRACHEOSTOMY TUBE
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD.,; boundary road; hythe, kent, CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.,; boundary road; hythe, kent, CT21 6JL; UK CT21 6JL
• Manufacturer Contact: michele seliga ; 1265 grey fox rd; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 5082563
• MDR Text Key: 26006628
• Report Number: 2183502-2015-00672
• 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: Followup
• Report Date: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 100/515/075
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1