MAUDE Adverse Event Report: NULL PORTEX; TRACHEOSTOMY TUBE

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that patient appeared to have ?chewed' on the line which eventually made the cuff line broke off.This is the first time we have encountered this and posed a serious airway issue wherein we needed to reintubate the patient.No further adverse patient effects were reported.

Manufacturer Narrative

H10: device evaluation: photo received: one (1) photo was attached in agile attachments for evaluation.Results: inflation line broken off was found and a bitten mark was observed; the complaint was confirmed.One (1) sample of our inventory was taken in attempt to replicate the failure mode pulling the tube to broken off in half.Results: it was not possible replicate the failure mode, the inflation line cannot be broken off in half and the damage on tube does not similar compared with the sample returned.Based on the analysis conducted in the photo provided, the most probable root cause is that tube was broken off by the end user since a bitten mark was appreciated on the tube per photo received.No action taken required since the failure mode reported is not attributable to the manufacturing process.The cause of the reported problem was traced the the user manipulation of the device.

• Brand Name: PORTEX
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section G): NULL
• MDR Report Key: 12271198
• MDR Text Key: 264926067
• Report Number: 3012307300-2021-08020
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention