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

Catalog Number	101/860/060CZ
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
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 there was an air leak with the cuff.There was patient involvement and no patient harm reported.
Additional Manufacturer Narrative
Investigation summary: one used decontaminated sample 10009163-001 6mm deht blu suctionaid sub-assy was received for investigation without its original packaging.Under visual inspection the sample appeared to be in good condition.During manufacturing process, the devices are 100% inflation tested, which includes inflating each device cuff and leaving for a 12-hour period.Reductions in pressure over this time are considered a failure and the device would be rejected.The inflation test was repeated on the received sample.We inflated cuff by a syringe filled with air and we put returned device under water.Air leak was detected from pilot balloon - between pilot balloon and valve.Affected material 10001429-001 infl.Line s/assy soft-seal 6mm is manufactured in smiths medical tijuana.We are forwarding this investigation to mtij to identify the root cause.Complaint sample was resent to this site.A device history record could not be completed as no lot number was received.

• Brand Name: PORTEX BLU SELECT 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: 19634120
• Report Number: 3011237704-2024-00132
• Device Sequence Number: 7400204
• Product Code: BTO
• UDI-Device Identifier: 15019517076127
• UDI-Public: (01)15019517076127
• 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): 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): 08/07/2024

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: 101/860/060CZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 08/07/2024
• 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