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 Inflation Problem (1310)

Patient Problem Insufficient Information (4580)

Event Date 07/07/2023

Event Type  malfunction  

Manufacturer Narrative

Other text: g5: 510k is blank this catalog number is not sold in the united states.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 Description

It was reported that the cuff of the product doesn't work.Not "voluming".Patient involvement is unknown.

Manufacturer Narrative

One used decontaminated device sample was received in a plastic bag.Under visual inspection the sample appeared to be in good condition.A functional inflation test was performed, and it was found that it was not possible to inflate the cuff as it leaked.The root cause remains unknown as it was not clear when the cuff leak was observed (pre-test or during use after insertion).A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No trend of confirmed complaints in relation to this issue was identified.

• 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): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17626895
• MDR Text Key: 321988982
• Report Number: 3012307300-2023-08411
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: No
• 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: 3907030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1