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

Model Number	100/897/080CZ
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	02/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Information received a smiths medical tracheostomy|pvc - portex tubes pdt uniperc was involved in incident where airway obstruction occurred.A swab was retained inside the tracheostomy tube and dislodged into the patients airway with suction tubing, thetube is opaque and the swab not seen.Patient required sedation and bronchoscope to remove the swab from the bronchus.This is not describing malfunction of the device, however the device was involved in the serious injury that occurred when swab detached by caregiver and dislodged into airway.

• Brand Name: PORTEX
• Common Device Name: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer (Section G): NULL; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12214883
• Report Number: 3012307300-2021-07516
• Device Sequence Number: 1323404
• Product Code: BTO
• UDI-Device Identifier: 15019315107207
• UDI-Public: 15019315107207
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083031
• 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): 06/20/2023

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
• Device Expiration Date: 12/03/2025
• Device Model Number: 100/897/080CZ
• Device Catalogue Number: 100/897/080CZ
• Device Lot Number: 4070559
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown