MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX BLU SELECT 7.5 SUCTIONAID, CUFFED, NON-FENESTRATED; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	101/860/075
Medical Device Problem Code	No Pressure (2994)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the user "confirmed the cuff pressure of the pilot balloon and it was 0".The event occurred in early feb-2023, exact date unknown.This occurred during patient use, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
B3: month and year of event have been provided, day is unknown.D4: full udi and item lot number are not available; no information has been provided 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
H3 and h6 - updated.One device was received for investigation.The device was visually inspected and functionally tested.After 12 hours the cuff was still fully inflated.The reported complaint is not confirmed.A review of the device history records could not be completed as no lot number was provided by the customer.

• Brand Name: PORTEX BLU SELECT 7.5 SUCTIONAID, CUFFED, NON-FENESTRATED
• 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: 18935433
• Report Number: 3011237704-2024-00065
• Device Sequence Number: 20593649
• Product Code: BTO
• UDI-Device Identifier: 15019517076141
• UDI-Public: (01)15019517076141
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

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: Other
• Device Model Number: 101/860/075
• Device Catalogue Number: 101/860/075CZ
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/11/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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