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

Model Number	100/562/000
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Pneumothorax (2012)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event; lot number, expiration date and device manufacture date is unknown, no information has been provided to date.The investigation was limited because no sample or product photo was provided.The affected guidewire is manually assembled, and 100 percent visually inspected before sealing.No trend of similar customer complaints was identified.Without the sample we are unable to determine true root cause of this issue.A device history record (dhr) review could not be performed as no valid lot number was provided.If the product is returned the manufacturer will re-open the complaint for further investigation.
Event or Problem Description
It was reported that during a percutaneous tracheostomy, there was a technical difficulty related to ?bending and deformity? of the atraumatic guide.This delay was related to transient loss of access to the trachea with secondary patient desaturation.A tracheostomy cannula was advanced, but cannot move forward, so it had to be extracted and the procedure restarted with subsequent difficulty in entering the trachea.After several attempts, another device without a fenestra was advanced.During the percutaneous tracheostomy the patient presented a complication of tension pneumothorax on the right, it was suspected by the customer this complication was possibly due to the use of the percutaneous tracheostomy set.The customer provided an invalid lot number for this item.Icu medical attempted to obtain a valid lot number and the customer informed that no further information is available.

• Brand Name: PORTEX TUBES PDT ULTRAPERC
• Common Device Name: 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 16763651
• Report Number: 3012307300-2023-04260
• Device Sequence Number: 16883902
• Product Code: JOH
• UDI-Device Identifier: 15019315106750
• UDI-Public: 15019315106750
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 04/18/2023

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
• Operator of Device: Health Professional
• Device Model Number: 100/562/000
• Device Catalogue Number: 100/562/000CZ
• 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: 03/30/2023
• Initial Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Sex: Unknown