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

Model Number	100/815/070
Medical Device Problem Codes	Inflation Problem (1310); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One sample and three photos were received for evaluation.A device history record (dhr) review was performed which indicated all inspections were completed and no issues were noted during manufacture.Visual and functional testing were performed and the reported issue was confirmed.During visual inspection, no defects were found in the photos.During testing of the cuff on the returned sample, the sample failed the inflation testing and presented bubbles.The root cause of the reported issue on the returned sample was air leak however; the probably root cause was noted as an occurrence related to the handling follow shipment from the manufacturer.Manufacturing controls and instructions for use (ifu) are in place to help prevent occurrence of the reported issue.D5 is nurse.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that during cuff testing, prior to use, the product presented a bubble indicating a tear in the cuff or balloon.No patient involvement reported.

• Brand Name: PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE
• Common Device Name: BLUE LINE ULTRA 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15436632
• Report Number: 3012307300-2022-19368
• Device Sequence Number: 14845142
• Product Code: BTO
• UDI-Device Identifier: 15019315045349
• UDI-Public: 15019315045349
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K030381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 100/815/070
• Device Catalogue Number: 100/815/070
• Device Lot Number: 4068707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2022
• Initial Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown