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

Model Number	100/810/075
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cuff of tracheostomy didn't inflate.The video provided by the customer shows patient involvement.No detail of patient harm provided in the form.Event occurred immediately on use.Event occurred in the hospital.The issue was reported as resolved.Customer opened a new kit of the same iem number.
Additional Manufacturer Narrative
H3 - other: device has not been returned to date.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
No product was returned, and the complaint was confirmed based on a customer provided video.Because the cuff leak was observed after placement it is the most probable that the reported failure occurred during tracheostomy procedure due to contact with sharp edge which is in conflict with instruction for use.Unfortunately, without the sample we are unable to determine the true root cause of this issue.No trend of confirmed complaints in relation to this issue was identified.A device history record (dhr) review showed there were no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.

• Brand Name: PORTEX BLUE LINE ULTRA SMOOTH INNER CANNULA
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL CZECH REPUBLIC A. S; olomoucka 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18499017
• Report Number: 3011237704-2024-00014
• Device Sequence Number: 18118138
• Product Code: BTO
• UDI-Device Identifier: 15019517076295
• UDI-Public: (01)15019517076295(17)280217(10)4281087
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024

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 Model Number: 100/810/075
• Device Catalogue Number: 100/810/075CZ
• Device Lot Number: 4281087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 01/21/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2023
• 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