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

Catalog Number 100/800/075CZ

Device Problem Defective Device (2588)

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

Event Date 12/28/2019

Event Type  malfunction  

Event Description

It was reported that the cuff of tracheotomy tube was not getting inflated after the opening of the packet during surgery.No patient injury was reported.

Manufacturer Narrative

Several device history records (dhr) were reviewed and there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.Two product samples were received for evaluation.Visual and functional testing were performed.Under visual inspection the samples appeared to be in good condition.The inflation test was repeated on the received samples.It was observed that one sample was not even possible to inflate cuff because it leaks so badly.The second sample remained fully inflated (no leak found).Customer reported that cuff leak was found after opening of unit pack but on returned samples there were found some dried secretions which indicated that products were used.Therefore it is the most probable that cuff tear 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.Pma/510k is unknown.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX BLUE LINE ULTRA CUFFED TRACHEOSTOMY 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; pancha sayar,; minneapolis, MN 55442
• MDR Report Key: 15418185
• MDR Text Key: 305924362
• Report Number: 3012307300-2022-19140
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/800/075CZ
• Device Lot Number: 3725987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1