MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TUBE, TRACHEAL (W/WO CONNECTOR)

Device Problem Inflation Problem (1310)

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

Event Type  Injury  

Event Description

It is reported that the trach is not inflating.

Event Description

It was reported that a tracheostomy change was done at bedside with ear, nose, throat and respiratory therapist.Cuff was checked in tracheostomy prior to being placed, the cuff did not appear to inflate as much as we thought it should but felt no leaks around the cuff so ear, nose, throat and respiratory therapist placed tracheostomy.Upon placement patient had larger leak than before and cuff was inflated in old tracheostomy to compare.The cuff in the old tracheostomy inflated quite a bit more so another tracheostomy change was done to remove faulty tracheostomy.The patient tolerated both tracheostomy changes well with no desaturations or bleeding at trach site.No patient injury reported.

Manufacturer Narrative

Other text: this mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.A manufacturing device history record (dhr) review was not performed because the lot number was not provided; therefore, device history record review could not be completed the results of the complaint investigation do not indicate a problem with the manufacture of the device.A product sample was received for evaluation.Visual and functional testing were performed.Physical condition of sample received was in used conditions, without original packaging and with its certificate of safe handling.As part of the investigation, two images were also provided.Based on images attached, the condition reported in complaint is not visible, the failure mode cannot be confirmed.Sample was filled with 5 cube centimeters (cc( of air to conduct a leak test to see if there was any functional problem.When the sample was inflated with air, the cuff only inflated on one side.The pilot balloon was manipulated, according to the instruction for use and the cuff inflated.After the whole cuff inflated, it was deflated and inflated four times, each time the cuff inflated completely and symmetrically, based on analysis the complaint is not confirmed.The directives in instruction for use indicate: attach a syringe to the pilot balloon and slowly inflate the cuff with 5ml of sterile water.If the cuff does not inflate completely, squeeze the pilot balloon wile gently manipulating the cuff from the shaft.If the cuff still does not inflate, use a new tube, save the old tube, and call manufacture's customer service.Deflate the cuff prior to intubations.Root cause could not be determined since the sample successfully passed functional test.No corrective actions were taken since the complaint was not confirmed.Additional information provided in:d3, corrected data: corrected information: b5, d10 , g1, g2 h3 and, h5.

• Brand Name: PORTEX
• Type of Device: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13118359
• MDR Text Key: 282971837
• Report Number: 3012307300-2021-13505
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 12/19/2022
• 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
• Patient Outcome(s): Other