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

Catalog Number 100/860/080CZ

Device Problem Leak/Splash (1354)

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

Event Date 01/11/2024

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (b)(6).Reason device not evaluated by mfg: other; device was not returned to manufacturer.Investigation summary: the investigation of the complaint was limited because no sample was returned.During the 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.History of internal ncrs showed that there was a raised internal nonconformity report ncr1826 due to cuff tear which was found after inflation testing.Corrective actions have been taken, including initiation of quality alert, training of the whole production team during a production town hall meeting, replacement of gauges and equipment with sharp edges by blunt versions, warnings in manufacturing procedures, and establishing better organization in the affected workplace.No trend of confirmed complaints in relation with this issue was identified.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.Unfortunately, without the sample the true root cause of this issue could not be identified.

Event Description

It was reported that before the operation, the doctor prepared the tracheotomy tube to check for air bag leakage and replaced it with a new tracheotomy tube.There was patient involvement and no patient harm/adverse event reported.

• 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: 18759386
• MDR Text Key: 336082050
• Report Number: 3011237704-2024-00043
• Device Sequence Number: 1
• Product Code: BTO
• 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: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/860/080CZ
• Device Lot Number: 4134728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• 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