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

Catalog Number 100/515/080

Device Problems Fitting Problem (2183); Component or Accessory Incompatibility (2897)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

The user facility reported that an attempt to suction a patient's tracheostomy tube was made, but the suction catheter would not pass through the tracheostomy tube lumen.No incident related medical sequela was reported.

Manufacturer Narrative

One used sample was returned for evaluation.Visual inspection did not reveal any obvious defects.The inside of the tube appeared to be free from any obstruction.Functional testing was performed by using an 8.0mm obturator to detect any obstruction inside the tube.The obturator passed through the tube without obstruction or issue.No fault was found with the returned sample.

• Brand Name: PORTEX BLUE LINE STUCTIONAID 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: 5101302
• MDR Text Key: 26677513
• Report Number: 2183502-2015-00702
• 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: Health Professional
• Type of Report: Followup
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/515/080
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1