MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBE CUFFED, 9MM 1/CA*******EXTERNAL_; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	100/897/090CZ
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a clinician did a pre-insertion check of cuff and it was found that the cuff failed under inflated pressure.There was no patient involvement.
Additional Manufacturer Narrative
E1: phone number: (b)(6).G4: 510k is unknown.No product information has been provided.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
H2) device evaluation: h3, h6: the device was returned for root cause analysis and the investigation findings concluded after visual inspection and functional testing, the customer problem was duplicated.The manufacturing process includes 100% inflation testing 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.For this returned device, it was found that it was not possible to inflate the cuff as it leaked badly, and the source of the leak was a tear in the cuff.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacturing.H10 updated.

• 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: 21366442
• Report Number: 3011237704-2025-00027
• Device Sequence Number: 8452773
• Product Code: BTO
• UDI-Device Identifier: 15019315107214
• UDI-Public: (01)15019315107214(17)290715(10)6014868
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2025

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: 100/897/090CZ
• Device Lot Number: 6014868
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown