MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX PERC DILATION KIT W/ SINGLE STAGE DILATOR & BLUSELECT SUCTIONAID TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	101/563/090
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the healthcare provider was unable to pass white slim dilator through purple introducer due to narrowing of dilator.The event did prolong the tracheostomy.There was reported patient involvement, but no patient harm.
Additional Manufacturer Narrative
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; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: PORTEX PERC DILATION KIT W/ SINGLE STAGE DILATOR & BLUSELECT SUCTIONAID TUBE
• 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 lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22208137
• Report Number: 3012307300-2025-07136
• Device Sequence Number: 20761799
• Product Code: BTO
• UDI-Device Identifier: 15019517103427
• UDI-Public: (01)15019517103427(17)280504(10)6098246
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173912
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2025

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: 101/563/090
• Device Lot Number: 6098246
• 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: 05/21/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 06/14/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2025
• 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 Age: 30 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White