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

Model Number	6.5 MM
Medical Device Problem Codes	Separation Failure (2547); Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.This was reported to occur on seven occasions as incidents described.
Additional Manufacturer Narrative
Information was received on 14-apr-21 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 no defects were detected in cuff and pilot balloon missing was detected therefore ?cuff won't inflate" failure mode cannot be confirmed since the pilot balloon is missing to connect a syringe to inflate the cuff.Based on the evidence, the complaint was not confirmed, and no fault was found.

• Brand Name: PORTEX
• Common Device Name: ENDOTRACHEAL
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 11517517
• Report Number: 3012307300-2021-02241
• Device Sequence Number: 17165629
• Product Code: BTR
• UDI-Device Identifier: 15019315059513
• UDI-Public: 15019315059513
• Combination Product (Y/N): N
• PMA/510(K) Number: K081086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 04/03/2024
• Device Model Number: 6.5 MM
• Device Catalogue Number: 100/189/065
• Device Lot Number: 3779246
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/01/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention