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

Catalog Number 100/150/065

Device Problem Inflation Problem (1310)

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

Event Date 02/17/2020

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacturing.The product was returned and visual testing was performed no damages were detected on the samples.The reported issue could not be determined since the complaint was not confirmed due to the fact the accuracy test was successfully passed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that after intubation and inflation of the cuff, no external visibility of the state of inflation of the cuff because the external cuff could not be inflated.No patient injury reported.

• Brand Name: PORTEX ENDOTRACHEAL TUBES
• Type of Device: TUBE, TRACHEOSTOMY (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: 15443270
• MDR Text Key: 306169294
• Report Number: 3012307300-2022-19567
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/18/2022

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 Catalogue Number: 100/150/065
• Device Lot Number: 19090265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/21/2022
• Initial Date FDA Received: 09/18/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1