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

Model Number	101/860/070
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: 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 there was an air leak from the cuff.No adverse patient effects were reported by the customer.It was reported that no further information is available.
Additional Manufacturer Narrative
Other text: h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.One used decontaminated device was returned for investigation.Under visual inspection the sample appeared to be in good condition.An inflation test was performed, and it was found that the device could not pass as the cuff was deflating during inflation from a tear in pilot balloon.The complaint was confirmed.A root cause for the failure could not be determined.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.No action was taken, the issue will be monitored, and further actions taken accordingly.

• Brand Name: PORTEX TUBES BLUSELECT SUCTIONAID
• 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: 17368428
• Report Number: 3012307300-2023-07468
• Device Sequence Number: 3874975
• Product Code: BTO
• UDI-Device Identifier: 15019517076134
• UDI-Public: 15019517076134
• 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): 08/23/2023

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: 101/860/070
• Device Catalogue Number: 101/860/070CZ
• Device Lot Number: 4285771
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/04/2023
• 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: 07/03/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2022
• 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