MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX BLUSELECT SUCTIONAID CUFFED TRACHEOSTOMY; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	101/810/090CZ
Medical Device Problem Codes	Deflation Problem (1149); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One used decontaminated sample was returned for evaluation.Visual inspection was performed, the sample appeared to be in good condition.Inflation test was also performed on the received sample by inflating cuff by a syringe filled under water.Air leak was detected from pilot balloon - between pilot balloon and valve.The device history review of the reported lot number found no non-conformities during the manufacturing process.Affected device is manufactured in smiths medical tijuana.Investigation was forwarded to mtij to identify the root cause.Complaint sample was resent to this site.
Event or Problem Description
It was reported that the device had a leak after insertion.The patient could breath normally whose cannula became more slimy.There was patient involvement but no harm reported.
Additional Manufacturer Narrative
The following fields were updated with corrections: h6.B, c, & d codes.

• Brand Name: PORTEX BLUSELECT SUCTIONAID CUFFED TRACHEOSTOMY
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL CZECH REPUBLIC A. S; olomoucká 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19610751
• Report Number: 3011237704-2024-00128
• Device Sequence Number: 6335204
• Product Code: BTO
• UDI-Device Identifier: 15019517076325
• UDI-Public: (01)15019517076325(17)271207(10)4306027
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2024

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 Catalogue Number: 101/810/090CZ
• Device Lot Number: 4306027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/23/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown