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

Catalog Number	100/870/080CZ
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cannula was cracked and breaking.This occurred with 2 cannulas.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
B3.Date of event: month and year of event have been provided, but day is unknown.H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
Investigation summary: no product sample was received.Investigation of this complaint was done based on photos.On the photos there is shown one 005/073/680 9mm blu thin wall inner cannula with visible crack as described by customer.Affected inner cannula is disposable device which is regularly cleaned by customer and therefore it shall be replaced based on its condition as described in ifu (instructions for use).To verify blue line ultra-thin wall inner cannulas durability, we carried out informative testing on randomly selected inner cannula samples of each size (6.0mm - 10.0mm, both fenestrated and non-fenestrated versions) from current batches to measure their performance using established standard test methods.Based on results of the testing, current blu thin wall inner cannulas were found to be suitable for its function.Unfortunately, without the sample / more information we are unable to further assess this incident nor further investigate.Investigation might continue if sample or more information is provided.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.

• Brand Name: PORTEX BLUE LINE ULTRA SUCTIONAID CUFFED TRACHEOSTOMY TUBE & INNER CANNULA
• Common Device Name: 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20610492
• Report Number: 3011237704-2024-00242
• Device Sequence Number: 7411303
• Product Code: BTO
• UDI-Device Identifier: 15019315104862
• UDI-Public: (01)15019315104862(17)281220(10)4397505
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K030570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 100/870/080CZ
• Device Lot Number: 4397505
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/22/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown