MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	101/810/070
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the portex tube was defective.The doctor was unable to inflate the cuff.The user confirmed the same issue.This tube was never used.No report of patient injury.
Additional Manufacturer Narrative
Date of event is unknown.One used tracheostomy tube was received for investigation.The reported issue was confirmed during functional testing when the device cuff failed to inflate.The cuff leakage was traced to a tear in the cuff.During manufacture, this product is 100% inflation tested, with inflation failures resulting in the affected product being rejected.The investigation determined that this product would not have passed this testing.A review of internal ncrs showed that there was raised internal nonconformity report due to a cuff tear which was found after inflation test.Corrective actions have been taken including initiation of quality alert, training of whole production during production town hall meeting, replacement of gauges and equipment with sharp edges by blunt versions, warning in manufacturing procedure and establishing better organization on affected workplace.A review of manufacturing device history records for the reported lot found no recorded conformances, and determined this lot was manufactured after the implementation of the aforementioned corrective actions.Although this review found no previously recorded issues, as the customer states the issue occurred prior to use of the device, the investigation attributed the root cause to a problem during the manufacturing process.Trends will be monitored with action taken as necessary.

• Brand Name: PORTEX TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16611365
• Report Number: 3012307300-2023-03005
• Device Sequence Number: 12045042
• Product Code: BTO
• UDI-Device Identifier: 15019517076288
• UDI-Public: 15019517076288
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2023

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
• Operator of Device: Health Professional
• Device Model Number: 101/810/070
• Device Catalogue Number: 101/810/070CZ
• Device Lot Number: 4285856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2023
• 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: 03/03/2023
• Initial Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2022
• 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