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

Model Number 526060

Device Problem Crack (1135)

Patient Problem Decreased Respiratory Rate (2485)

Event Type  Injury  

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.

Event 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.

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
• Type of Device: 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: 16244125
• MDR Text Key: 308131240
• Report Number: 3012307300-2023-00673
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 10351688041128
• UDI-Public: 10351688041128
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K903730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White