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

Model Number	100/597
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Decreased Respiratory Rate (2485)
Date of Event	11/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that following an episode of respiratory failure experienced by a 76-year-old patient, the tracheostomy tube tightening ring was found to be broken 2-3 days after the initial insertion.This event exposed the patient to the risk of loss of airway control with a risk of death.This incident resulted in the early change of the tube.
Additional Manufacturer Narrative
Other, other text: one unit was returned for investigation.Under visual inspection we noticed that blue locking lever is incorrectly assembled with flange body (it cannot lock).It was found that the complained issue could be duplicated.Due to fact that incident happened 2-3 days after the initial insertion it is the most probable that locking lever was unscrewed during use and then incorrectly assembled back.The root cause was identified to be in design of adjustable flange which allows to unscrew blue locking lever.The root cause was identified to be in design of adjustable flange which allows to unscrew blue locking lever.

• Brand Name: PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• 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: 16111798
• Report Number: 3012307300-2023-00162
• Device Sequence Number: 14866579
• Product Code: BTO
• UDI-Device Identifier: 15019315107146
• UDI-Public: 15019315107146
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/15/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2023
• Device Model Number: 100/597
• Device Catalogue Number: 100/597/080CZ
• Device Lot Number: 3954728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/09/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male