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	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: lot number, expiration date, and h4: manufacture date are unknown, no information has been provided to date.Device evaluation: no lot number was provided therefor no device history report (dhr) review could be completed.One decontaminated sample was returned for investigation.Visual inspection showed the inflation line was cut.The inflation test that occurs during manufacturing was repeated on the received sample.It was found that sample cannot pass this 12 hour test due to leak from inflation line cut.It is improbable that such defect would not be detected upon manufacturing.Complaint history was checked and there is no trend of similar customer complaints therefore this issue is considered to be isolated incident only.Root cause of this incident remains unknown.No actions have been taken at this time.
Event or Problem Description
It was reported that during the pre-use check, the customer tried to put air in the cuff but could not.The cuff would not inflate.No patient injury reported.It has been reported that no additional information will be available for this event.

• 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: 16810094
• Report Number: 3012307300-2023-04529
• Device Sequence Number: 14950489
• 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
• Report Date (Section B): 04/25/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 04/25/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown