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

Catalog Number	100/870/085CZ
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that cracks were found in the inner cannula prior to use.There was no patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
H6.Investigation codes: updated.Investigation summary: no product sample was received.Investigation of this complaint was done based on video which was provided by customer.The video shows the product 005/073/685 8.5mm blu thin wall inner cannwith stop ring with defect described by the customer.To verify blu thin wall inner cannulas durability, informative testing on randomly selected inner cannula samples of each size (6.0mm - 10.0mm, both fenestrated and non-fenestrated versions) were conducted in the past year 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 their 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 will be provided.

• Brand Name: PORTEX BLUE LINE ULTRA SUCTIONAID CUFFED TRACHEOSTOMY TUBE W/ 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: 19566580
• Report Number: 3011237704-2024-00121
• Device Sequence Number: 15197269
• Product Code: BTO
• UDI-Device Identifier: 15019315104879
• UDI-Public: (01)15019315104879(17)270606(10)4244648
• 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): 07/25/2024

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: 100/870/085CZ
• Device Lot Number: 4244648
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2022
• 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