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

Model Number	101/870/090CZ
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a smiths medical tracheostomy cuff was leaking air from the cuff.There was no patient injury and no reported adverse events.
Additional Manufacturer Narrative
Device evaluation: one smiths medical portex tube bluselect was returned for analysis in a good condition.During analysis under water, it was found that there were several holes across pilot balloon diameter which caused reported leak.Based on the evidence, the complaint was confirmed, and the problem source of the reported event was noted to be user interface.
Additional Manufacturer Narrative
Other, other text: corrected data: b1, corrected data: corrected data: b1-product problem.

• Brand Name: PORTEX
• 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; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; akasaka, minato-ku, tokyo; minneapolis, MN 55442
• MDR Report Key: 12059746
• Report Number: 3012307300-2021-06486
• Device Sequence Number: 3870569
• Product Code: BTO
• UDI-Device Identifier: 15019517076240
• UDI-Public: 15019517076240
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2023

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: 101/870/090CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2021
• Supplement Date Received by Manufacturer: 07/13/2021; 06/14/2023
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 08/12/2021; 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian