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

Model Number	101/870/090CZ
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Under visual inspection the sample appeared to be in good condition.Then we inflated cuff by a spare syringe filled with air.Air was found to be leaking from connection between pilot balloon and inflation line as described by customer (note: customer described that a fluid was leaking from this connection.Inflation system shall be filled by air not by any fluid).Then we slightly pulled inflation line and smooth detachment from pilot balloon was observed.Rout cause (b)(4) was created on (b)(6) 2021, in order to perform a complete cause analysis for the failure mode reported for inflation line detached; the analysis performed in the sample received concluded that the occurrence of this failure condition could be caused by: not enough thf solvent at joint cause by bad condition on the thf feeder system equipment.Dhr: a review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.
Event or Problem Description
It was reported that during the use of the product, leakage of fluid between the pilot balloon and the inflation line was found.The customer then stopped using the product.No patient injury was reported.
Additional Manufacturer Narrative
Under visual inspection the sample appeared to be in good condition.Then we inflated cuff by a spare syringe filled with air.Air was found to be leaking from connection between pilot balloon and inflation line as described by customer (note: customer described that a fluid was leaking from this connection.Inflation system shall be filled by air not by any fluid).Then we slightly pulled inflation line and smooth detachment from pilot balloon was observed.Root cause (b)(4) was created on (b)(6) 2021, in order to perform a complete cause analysis for the failure mode reported for inflation line detached; the analysis performed in the sample received concluded that the occurrence of this failure condition could be caused by: not enough thf solvent at joint cause by bad condition on the thf feeder system equipment.Dhr: a review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.
Event or Problem Description
It was reported that during the use of the product, leakage of fluid between the pilot balloon and the inflation line was found.The customer then stopped using the product.No patient injury was reported.

• Brand Name: PORTEX TRACHEOSTOMY TUBES
• 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): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; sapporo city, hokkaido; minneapolis, MN 55442
• MDR Report Key: 13506092
• Report Number: 3012307300-2022-03111
• Device Sequence Number: 20112547
• Product Code: BTO
• UDI-Device Identifier: 15019517076240
• UDI-Public: 15019517076240
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/10/2022

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
• Operator of Device: Health Professional
• Device Model Number: 101/870/090CZ
• Device Catalogue Number: 101/870/090CZ
• Device Lot Number: 4087777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 02/10/2022
• 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