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

Model Number 100/860/080

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2023

Event Type  malfunction  

Event Description

It was reported that due to air bag leakage, the ventilator alarm went off and air could not be delivered normally, requiring replacement of the tracheostomy tube and accessories.There was patient involvement, but no harm/adverse event was reported.

Manufacturer Narrative

Initial reporter phone: (b)(6).Customer claimed the cuff leaked during use.The investigation of the complaint was limited because no sample was returned; therefore, visual and functional testing could not be performed.During the manufacturing process the devices were 100% inflation tested, including inflating each device cuff and leaving it for a 12-hour period.Reductions in pressure over this time are considered a failure and the device would be rejected.Each cuff is also recommended for testing by the customer prior to use per the instructions for use.Due to fact that cuff leak was observed after placement, it is probable that the reported failure occurred during the tracheostomy procedure due to contact with sharp edges.Unfortunately, without the sample, the true root cause of this issue cannot be determined.A review of the device history records shows there were no observations recorded during manufacturing to suggest an issue of this nature would occur with this lot of products.Another one customer complaint was received against the affected lot number that describes the same issue but is not confirmed.There is no trend of confirmed complaints in relation with the identified issue.

• Brand Name: PORTEX BLU SUCTIONAID CUFFED TRACHEOSTOMY TUBE
• Type of Device: 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18608357
• MDR Text Key: 334291765
• Report Number: 3011237704-2024-00029
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315104725
• UDI-Public: (01)15019315104725(17)260310(10)4110693
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 100/860/080
• Device Catalogue Number: 100/860/080CZ
• Device Lot Number: 4110693
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1