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

Model Number	526060
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Decreased Respiratory Rate (2485)
Date of Event	11/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cannula begins to crack after 1-3 days of insertion and needs to be replaced.The issue took place in the patient's home.There has been no report of patient injury or no observable clinical symptoms or a change in symptoms identified in the patient, after trach replacement took place.
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
H6.Health impact, event problem and evaluation codes: updated.No product was returned for investigation therefore are unable to confirm the reported complaint.Device history review of the reported lot number showed no non-conformities of the reported lot number during the manufacturing process.If the product is returned, the manufacturer will reopen the complaint for further investigation.

• Brand Name: PORTEX TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16244006
• Report Number: 3012307300-2023-00670
• Device Sequence Number: 6306945
• Product Code: BTO
• UDI-Device Identifier: 10351688041128
• UDI-Public: 10351688041128
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K903730
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 526060
• Device Catalogue Number: 526060
• Device Lot Number: 4230815
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Unknown
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White