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)
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
Date of event is unknown, no information has been provided to date.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
Other, other text: h3.Device evaluated by manufacturer and 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: 16244088
• Report Number: 3012307300-2023-00672
• Device Sequence Number: 6409024
• 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