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

Model Number	100/897/090
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Premature Separation (4045)
Health Effect - Clinical Code	Decreased Respiratory Rate (2485)
Date of Event	09/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation of this complaint was done based on received photos.Photos are showing a shelf carton with the product label and the trach tube with a detached connector.The photos confirm the customer's complaint; however the condition of the sample cannot be further evaluated from the photos.The complaint history was checked and no trend of confirmed customer complaints was identified.The root cause could not be identified.A review of the device history records (dhr) shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.
Event or Problem Description
It was reported that the end connector of the trach tube was found by staff to be detaching itself from the main body of the tube.The tube was changed on the unit.Additional information was received via customer response email (b)(6) 2022 stating the end of connector detached itself from main unit and the patient's body was warm to the touch.The situation was resolved by changing the tracheostomy tube to another one of the same size and type.

• 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): SMITHS MEDICAL INTERNATIONAL, LTD.; 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: 15574671
• Report Number: 3012307300-2022-23176
• Device Sequence Number: 14942292
• Product Code: BTO
• UDI-Device Identifier: 15019315107214
• UDI-Public: 15019315107214
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2022

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: 06/18/2026
• Device Model Number: 100/897/090
• Device Catalogue Number: 100/897/090CZ
• Device Lot Number: 4110703
• 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: 09/12/2022
• Initial Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2021
• 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 Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White