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

Model Number	100/199/085
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical intubation|portex endotracheal tubes malfunctioned.The pilot balloon was inflated prior to surgery with no issues.Their surgery was completed with no airway.Concerns however the pilot balloon became completely detached from the ett while still in situ at the end of procedure.This was noticed as the anesthetic practitioner attempted to deflate the cuff and it came away in he hand.There was reported to have been no injuries to the patient and the anaesthetist had no concerns throughout the procedure.
Additional Manufacturer Narrative
Corrected data: h 1 updated to malfunction reportable and not serious injury.
Event or Problem Description
Folllow up redaction required and correction.

• Brand Name: PORTEX
• Common Device Name: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 12214935
• Report Number: 3012307300-2021-07517
• Device Sequence Number: 1323405
• Product Code: BTR
• UDI-Device Identifier: 15019315022357
• UDI-Public: 15019315022357
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K790312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021

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
• Operator of Device: No Information
• Device Expiration Date: 03/18/2025
• Device Model Number: 100/199/085
• Device Catalogue Number: 100/199/085
• Device Lot Number: 3959419
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/26/2021
• Supplement Date Received by Manufacturer: 06/26/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1