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

Model Number 100/810/080

Device Problem Disconnection (1171)

Patient Problem Decreased Respiratory Rate (2485)

Event Date 11/07/2022

Event Type  Injury  

Manufacturer Narrative

Device lot number is unknown, no product 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 trach pilot line detached while in use.Medical intervention required.Patient was monitored closely until a new tracheostomy was inserted.Patient had tracheostomy insitu, no noted issues with the trach itself up until this point.Patient was then taken from icu to radiology department to have an mri.During the patient transfer from bed to trolley, it was noted that the blue pilot line was snapped off and disconnected in the bed.There was no force applied or reason why the pilot line would have been accidently pulled/caught that would account for it being disconnected.Patient was monitored closely until a new tracheostomy was inserted.

Manufacturer Narrative

Device evaluation: one device was received for investigation.Upon visual inspection the pilot balloon was found detached from the inflation line.The complaint was confirmed.The root cause was traced to manufacturing.No lot number was provided therefor no device history report (dhr) review could be completed.This issue will continue to be monitored and further actions taken accordingly.

• Brand Name: PORTEX BLU LINE ULTRA TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer (Section G): NULL; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; austin hospital 145 studley r; minneapolis, MN 55442
• MDR Report Key: 16224585
• MDR Text Key: 307907810
• Report Number: 3012307300-2023-00612
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K030381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 100/810/080
• Device Catalogue Number: 100/810/080CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/30/2022
• Initial Date FDA Received: 01/23/2023
• Supplement Dates Manufacturer Received: 05/11/2023
• Supplement Dates FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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