MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX BLUE LINE ULTRA; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number 100/800/075

Device Problem Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Date 11/22/2023

Event Type  malfunction  

Event Description

It was reported that the tracheostomy cannula had a pierced cuff.The distributor of this product is (b)(4).The product was not reprocessed, was used according to the manufacturer's instructions and as per the report this event it was not notified to the distributor by email.A measure action was taken after the problem was identified.According to the report, there is no sample to be collected, and there is no label also.The event was classified as type ii-medium risk.It is unknown if the event occurred during patient use and if there was anyone harmed.After the problem was identified and the device was replaced.

Manufacturer Narrative

D5: operator of device, e1: reporter name address, phone number and email are unknown.Complaint notification was received from brazil foreign regulatory authority anvisa.Original user and reporter are not known.No information is available.H3 - other: device has not been returned and is not available for investigation.Investigation summary: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.If the product is returned, the manufacturer will reopen this complaint for further investigation.No trend of confirmed complaints in relation with this issue was identified.

• Brand Name: PORTEX BLUE LINE ULTRA
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL CZECH REPUBLIC A. S; olomoucká 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18727060
• MDR Text Key: 335933409
• Report Number: 3011237704-2024-00039
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 100/800/075
• Device Catalogue Number: 100/800/075CZ
• Device Lot Number: 4202467
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1