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

Model Number	100/179/055
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the pre-use check, leakage of air from the cuff was observed.No patient injury.No additional information is available for this complaint.
Additional Manufacturer Narrative
A product sample was received and is awaiting evaluation and 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
Event problem and evaluation codes: updated.H3: device evaluated by manufacturer: updated.H10: device evaluation: three photos were included in agile attachments for evaluation; photos showed a bit damage of the tube tip.One sample was returned for investigation.The returned sample was received in used condition without original packaging.The samples were visually inspected under normal conditions of illumination to detect any condition that could cause failure mode.Damage was found on tube tip; the complaint was confirmed.The syringe was connected to the pilot balloon to allow air through the tube to confirm the place of the leak.An air leak was confirmed in the tube tip.Based on the analysis conducted in the sample provided, the failure mode was confirmed.The failure mode was possibly due to manufacture damage/failure to properly follow protocol.For corrective action, customer complaint notification was made to production personnel to explain the importance of adherence or following in the procedure.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX SOFT SEAL CUFF TRACHEAL 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; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-1-1 akasaka,; minneapolis, MN 55442
• MDR Report Key: 15456144
• Report Number: 3012307300-2022-19785
• Device Sequence Number: 6855524
• Product Code: BTR
• UDI-Device Identifier: 15019315022098
• UDI-Public: 15019315022098
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K790312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2023

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 Expiration Date: 08/01/2026
• Device Model Number: 100/179/055
• Device Catalogue Number: 100/179/055
• Device Lot Number: 4169638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2022
• Supplement Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2021
• 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