MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUE LINA ULTRA SUCTIONAID TRACH TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number 100/860/075

Device Problem Decrease in Pressure (1490)

Patient Problem Insufficient Information (4580)

Event Date 12/19/2022

Event Type  Injury  

Manufacturer Narrative

Device evaluation: no product was returned for investigation.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.Each cuff shall be also tested by customer prior use as per instruction for use (ifu).It is the most probable that the reported failure occurred during use due to contact with sharp edge which is in conflict with instruction for use (ifu).Without the sample we are unable to determine true root cause of this issue.If the device is received in the future an evaluation will be performed.A review of the device history records (dhr) shows there were no observations recorded during manufacturing to suggest an issue of this nature would occur with this lot of products.No trend of confirmed complaints in relation with this issue was identified.

Event Description

It was reported that on (b)(6) 2022, the patient underwent tracheostomy under local anesthesia with suction tracheostomy and accessories, and oxygen was received through the tracheostomy.The pressure of the balloon was measured at 28cmh2o at 12:30 on (b)(6) 2022, and the tracheostomy sleeve was connected to a ventilator to assist breathing, at 13:50, it was found that the patient's neck could hear obvious sputum sounds, the pressure was measured at 15cmh2o, and the pressure was measured to 12cmh2o after re-inflating to 28cmh2o for ten minutes.Replaced the air stomy sleeve and checked that the casing is not leaking after replacement.

• Brand Name: PORTEX BLUE LINA ULTRA SUCTIONAID TRACH TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; haicheng district; minneapolis, MN 55442
• MDR Report Key: 16553965
• MDR Text Key: 311406946
• Report Number: 3012307300-2023-02611
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K030570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100/860/075
• Device Catalogue Number: 100/860/075CZ
• Device Lot Number: 4134718
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 96 YR
• Patient Sex: Female