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	101/563/080
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
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 the subglottic port was cracked and unusable.It remains in situ as the patient is too unwell to replace the tube at this time.Unable to provide suction around the cuff to patient due to the faults.The operator of the device was a health professional.The issue was not resolved.There was no injury.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
H6.Codes: updated.The investigation of this complaint was carried out based on a photo.No product was returned therefore no device analysis could be completed.The root cause of this defect is currently unknown - it could be a molding defect or excessive force used when connector was connected to the syringe during use.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 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20724389
• Report Number: 3011237704-2024-00255
• Device Sequence Number: 3783094
• Product Code: BTO
• UDI-Device Identifier: 15019517103410
• UDI-Public: (01)15019517103410(17)261023(10)4408595
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2024

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: 101/563/080
• Device Lot Number: 4408595
• 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: 10/30/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2023
• 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