MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BLUE LINE ULTRA CUFFED TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Lot Number 3800131

Device Problem Leak/Splash (1354)

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

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

One used decontaminated sample was received in plastic bag for investigation.Under visual inspection we noticed that tube has been already used during tracheostomy procedure (based on secretions which were found to be on cuff surface).We also found that inflation line was cut by a sharp tool.Due to fact that cuff leak was observed during the use of the product it is the most probable that reported failure occurred during or after tracheostomy procedure due to contact with sharp edge which is in conflict with instruction for use.No trend of confirmed complaints in relation with this issue was identified.No information is provided to date.This remediation mdr was generated under protocol (b)(4) , as a result of warning letter cms# (b)(4).

Event Description

It was reported that when the device was under pressure it went down.No patient injury was reported.

• Brand Name: PORTEX BLUE LINE ULTRA CUFFED TRACHEOSTOMY TUBE
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15433551
• MDR Text Key: 305974958
• Report Number: 3012307300-2022-19341
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/15/2022

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 Lot Number: 3800131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/09/2022
• Initial Date FDA Received: 09/15/2022
• 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