MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TRACHEOSTOMY TUBE AND TUBE CUFF

Model Number 101/870/075CZ

Device Problem Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/16/2021

Event Type  malfunction  

Manufacturer Narrative

One device was returned for investigation.Under visual inspection, the sample appeared to be in good condition.An inflation test was done and after 12 hours of inflation, no leak was found.Device was also tested under water with no leak found as well.No lot number was provided so no dhr was done.

Event Description

It was reported that the customer started to use the product from oct/12.Four (4) days later, a phenomenon that was suspected to be air leak from the cuff was observed.The product was checked, but since no anomaly in it was confirmed, use was continued until nov/06.Then, when the customer checked the product after the removal of it, leakage of air from the cuff was detected.No patient injury.No additional information is available for this complaint.

• Brand Name: PORTEX
• Type of Device: TRACHEOSTOMY TUBE AND TUBE CUFF
• 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: david halverson ; 6000 nathan lane north; akasaka, minato-ku, tokyo; minneapolis, MN 55442
• MDR Report Key: 13048104
• MDR Text Key: 282547684
• Report Number: 3012307300-2021-12993
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076219
• UDI-Public: 15019517076219
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2021

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 Operator: Health Professional
• Device Model Number: 101/870/075CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1