MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BLUSELECT TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	101/816/070
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Sore Throat (2396); Stomatitis (4489); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after having used a different model of trach for several years, the patient's trach was changed to a portex bluselect tracheostomy tube.After changing to the new trach, the patient was experiencing problems which consisted of a bloody and swollen stoma.The ent "scoped" the patient and observed a bloody area on one side of the new trach and granulation on the other.The following week the ent again "scoped" the patient and noted the reported issues had gotten worse which resulted in removing the new trach and replacing with the previous model the patient's parent had with them.The customer noted that the instruction for use states "that if a patient has been on a particular trach for many years, they could experience problems with accepting this trach".
Additional Manufacturer Narrative
Date of event; d4: lot number, expiration date and h4: device manufacture date are unknown, no product information has been provided to date.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.
Additional Manufacturer Narrative
Device evaluation: no lot number was provided, therefor no device history report (dhr) review could be completed.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: PORTEX BLUSELECT TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17010083
• Report Number: 3012307300-2023-05715
• Device Sequence Number: 18059504
• Product Code: BTO
• UDI-Device Identifier: 15019517077414
• UDI-Public: 15019517077414
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2023

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: Lay User/Patient
• Device Model Number: 101/816/070
• Device Catalogue Number: 101/816/070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown