MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PVC - PORTEX TUBES PDT UNIPERC; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	100/897/080
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 phone number: (b)(6).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 as the clinicians inserted the trach tube into the patient, it did not inflate and then balloon was leaking.Another one was obtained from icu.The event occurred during patient use, but there was no report of patient injury.
Additional Manufacturer Narrative
One decontaminated sample was returned for investigation that the cuff leak during use.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.Under visual inspection the samples appeared to be in good condition.During manufacturing process, the devices are 100% inflation tested, which includes inflating each device cuff and leaving for a 12-hour period.Reductions in pressure over this time are considered a failure and the device would be rejected.The inflation test was repeated on the received sample.It was found that it is not even possible to inflate cuff as it leaks so badly.Source of leak was found to be tear in cuff.Cuff leak was not observed prior use it is the most probable that reported failure occurred during tracheostomy procedure or during use due to contact with a sharp edge or incorrect manipulation with flange.No signal of similar customer complaints was identified.

• Brand Name: PVC - PORTEX TUBES PDT UNIPERC
• 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 north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22851100
• Report Number: 3011237704-2025-00053
• Device Sequence Number: 14557727
• Product Code: BTO
• UDI-Device Identifier: 15019315060441
• UDI-Public: (01)15019315060441(17)280109(10)4310287
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 11/24/2025

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: 100/897/080
• Device Lot Number: 4310287
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2023
• 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