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

Model Number 100/897/090

Device Problems Detachment of Device or Device Component (2907); Premature Separation (4045)

Patient Problem Decreased Respiratory Rate (2485)

Event Date 09/09/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 301502287
• Report Number: 3012307300-2022-23176
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315107214
• UDI-Public: 15019315107214
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K083031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White