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

Catalog Number	101/860/085CZ
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when air was drawn from the cuff with a syringe, the water was removed.There was patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
B3: month and year of event have been provided; day is unknown.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.
Additional Manufacturer Narrative
H6.Investigation codes: updated investigation summary: one used decontaminated sample was returned for investigation.Tracheostomy tube inflation system is dedicated for inflation of cuff by air.Therefore, it shall be perfectly leak proof.There are only two possible reasons for a fluid inside inflation system - inflation system leak (e.G.Fluid can get into inflation system through cuff tear) or incorrect practice during use which do not respect instructions for use (e.G.Cleaning of inflation system by a fluid/inflation line flushed by a liquid instead of suction line by error/etc.).Under visual inspection the sample appeared to be in good condition, no water inside cuff (inflation system) was found.To verify if there was any leak in the inflation system, a 12-hour inflation test was done.It was found that after 12 hours the cuff was still fully inflated.Returned device was also submerged in water.No air leak nor fluid inside inflation system was observed.Based on investigation results no fault on returned sample was found.It is the most probable that a fluid was introduced into the inflation system due to a practice which is not in compliance with instructions for use.

• Brand Name: PORTEX TUBES BLUSELECT SUCTIONAID
• 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: 19566871
• Report Number: 3011237704-2024-00122
• Device Sequence Number: 6963889
• Product Code: BTO
• UDI-Device Identifier: 15019517076165
• UDI-Public: (01)15019517076165
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

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: 101/860/085CZ
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 07/25/2024
• 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