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

Model Number	101/860/085
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: month and year of event have been provided, day is unknown.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 "air missing during patient use".The event occurred in nov-2023.No patient harm or adverse event reported.
Additional Manufacturer Narrative
Device evaluation: one used decontaminated device sample was returned for investigation without its original packaging.Under visual inspection the sample appeared to be in good condition.An inflation test was performed on the received sample.It was confirmed that after twelve (12) hours the cuff was still fully inflated.The complaint was not confirmed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No action was taken, and no trend for similar customer complaints was identified.

• Brand Name: BLU SELECT SUCTIONAID CUFFED TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL CZECH REPUBLIC A. S; olomoucka 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18377612
• Report Number: 3011237704-2023-00013
• Device Sequence Number: 7617510
• Product Code: BTO
• UDI-Device Identifier: 15019517076165
• UDI-Public: (01)15019517076165(17)280223(10)4310532
• 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): 02/06/2024

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 Model Number: 101/860/085
• Device Catalogue Number: 101/860/085CZ
• Device Lot Number: 4310532
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/20/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2023
• 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