MAUDE Adverse Event Report: NULL PVC - PORTEX TUBES BLUE LINE ULTRA (BLU); TRACHEOSTOMY TUBE

Model Number 100/860/075

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 10/01/2021

Event Type  malfunction  

Event Description

It was reported that after the product was inserted into the patient, leakage of air from it was detected.This event was observed four times consecutively.No patient injury.

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Two (2) pictures are attached, during the analysis carried out, a top view of a product could be observed in the first image, then in the second image the inflated cuff can be observed.The returned sample was visually inspected at 12 to 16 inches and normal conditions of illumination.Per visual inspection, no damage was found on the components, no contamination, no failure mode conditions were observed, the sample meets all the specifications.No root cause could be determined since the complaint was not confirmed due sample provided does not shows failure mode reported, however current process mitigation related to failure mode reported were referred.No corrective actions are required since the complaint was not confirmed since sample successfully passed.

• Brand Name: PVC - PORTEX TUBES BLUE LINE ULTRA (BLU)
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section G): NULL
• MDR Report Key: 12725659
• MDR Text Key: 279259937
• Report Number: 3012307300-2021-10492
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 100/860/075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 10/31/2021
• Supplement Dates Manufacturer Received: 04/24/2023
• Supplement Dates FDA Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1