MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX BLU SELECT 8.5 SUCTIONAID, CUFFED, NON-FENESTRATED; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	101/860/085
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "it was tough to empty the cap of the pilot balloon." the event occurred testing.There was no patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
Month and year of event have been provided, day is unknown.Operator of device is unknown, no information has been provided to date.Device evaluation: one decontaminated sample was received for investigation.Within this investigation we inflated and deflated affected sample by spare syringe several times.We can confirm that no issues were observed during this inflation and deflation.The pilot balloon can be deflated smoothly.No fault was found.The complaint was not confirmed.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 product.No trend of similar complaints was identified.No action taken.

• Brand Name: PORTEX BLU SELECT 8.5 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: 18793650
• Report Number: 3011237704-2024-00048
• Device Sequence Number: 15277491
• 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
• Report Date (Section B): 02/27/2024

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: 101/860/085
• Device Catalogue Number: 101/860/085CZ
• Device Lot Number: 4310532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 02/27/2024
• 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