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

Catalog Number	101/870/080CZ
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that post turn there was audible cuff leak, and patient was also not ventilating adequately.The consultant attended and examined the patient and advised that patient needs to be supine for oral intubation as the tracheostomy tube appeared to be dislodged.There was patient involvement.
Additional Manufacturer Narrative
One used device was returned for evaluation.Under visual inspection the sample appeared to be in good condition.During manufacturing process, the devices are 100% inflation tested, it was confirmed that the cuff was still fully inflated.The testing could not duplicate the customer reported problem.The root cause of the issue was not determined as no problem was found.No further action.A device history record could not be completed as no lot number was received.

• Brand Name: PORTEX BLUSELECT SUCTIONAID TRACHEOSTOMY TUBE
• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20334398
• Report Number: 3011237704-2024-00204
• Device Sequence Number: 9592252
• Product Code: BTO
• UDI-Device Identifier: 15019517076226
• UDI-Public: (01)15019517076226
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 11/07/2024

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: 101/870/080CZ
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 11/07/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown