MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number 100/815/070

Device Problems Inflation Problem (1310); Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/21/2023

Event Type  malfunction  

Manufacturer Narrative

No device was returned for investigation therefore, the complaint could not be confirmed.A device history record (dhr) review showed no non-conformances or discrepancies during the manufacturing of the reported lot number.If the device is returned the manufacturer will re-open the complaint for further device analysis.

Event Description

It was reported that while inflating the cuff on the patient's trach, they were unable to inflate the cuff and found the cuff to be blown".The event occurred on the critical care floor.No adverse patient effects were reported by the customer.

• Brand Name: PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17162443
• MDR Text Key: 317469072
• Report Number: 3012307300-2023-06324
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315045349
• UDI-Public: 15019315045349
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/20/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: 100/815/070
• Device Catalogue Number: 100/815/070
• Device Lot Number: 4266843
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 85 KG