MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; ENDOTRACHEAL TUBE

Model Number 8.00MM

Device Problems Separation Failure (2547); Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 09/01/2020

Event Type  Injury  

Event Description

Reported a smiths medical intubation|portex endotracheal tubes sacett balloon was tested before the tube was inserted and then after inserting the tube, the balloon did not work and did not inflate.Also reported, in addition the cuff pilot tube is not installed well and when using it comes out by itself extubating patient.This was reported to occur on seven occasions as incidents described.

Manufacturer Narrative

Information was received on 14-apr-2021 indicating event date.Device evaluation completion date: 04/26/2021: device evaluation: one smiths medical portex endotracheal tube sacett was returned for analysis.Visual inspection was performed and indicated that hole was detected in cuff.During analysis, the returned sample was inflated using a syringe and was submerged under water to detect any leak in cuff and detect any discrepancies in pilot balloon, and lead was detected in cuff and no discrepancies were detected in pilot balloon; the complaint was confirmed.Based on the evidence, the complaint was confirmed, and the problem source of the reported event was noted to be manufacturing.

• Brand Name: PORTEX
• Type of Device: ENDOTRACHEAL TUBE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 11507164
• MDR Text Key: 240417613
• Report Number: 3012307300-2021-02199
• Device Sequence Number: 1
• Product Code: BTR
• UDI-Device Identifier: 15019315059544
• UDI-Public: 15019315059544
• Combination Product (y/n): N
• PMA/PMN Number: K081086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8.00MM
• Device Catalogue Number: 100/189/080
• Device Lot Number: 3858209
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/01/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention