MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLU SELECT SUCTIONAID TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	101/860/090
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while in use with a patient, there was cuff leakage.Suspected pinhole.Patient health effects are unknown.
Additional Manufacturer Narrative
B3: date of event, d4: lot number, expiration date and h4: manufacture date are 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.
Additional Manufacturer Narrative
Other text: h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.One used decontaminated device was returned.Under visual inspection the product appeared to be in good condition.A functional inflation test was performed.The cuff was deflating during inflation from damaged surface of cuff including pinholes confirming the complaint.Because the cuff leak was not observed prior to use it was the most probable that the failure occurred during the tracheostomy procedure or during use by the user due to unknown circumstances.The root cause of this issue remains unknown.A device history record (dhr) review could not be performed as the lot number was unknown.

• Brand Name: PORTEX BLU SELECT SUCTIONAID TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17443617
• Report Number: 3012307300-2023-07717
• Device Sequence Number: 16767800
• Product Code: BTO
• UDI-Device Identifier: 15019517076172
• UDI-Public: 15019517076172
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2023

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: 101/860/090
• Device Catalogue Number: 101/860/090CZ
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/18/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown