MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUE LINE PDT DIRECTIONAL TUBE; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/133/080
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation 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 on a surgical tracheostomy of an intensive care patient, before making an incision in the trachea, the outer leg is always checked according to routine.During this check, no hood leakage was detected without external influence, i.E.The cuff was not broken before.Additional information received via customer response email 12-oct-2022: product fault is for a leak.Resolved using a new tube size 7.No patient injury was reported.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Two product sample were received for evaluation.Visual and functional testing was performed.Results: rips was detected in cuff for two samples and a leakage was detected; complaint was confirmed.The root cause of the reported issue was found to be the cuff was damaged during the use of the product since no leaks were reported in the pre-use check and according to the instructions for use the cuff could be damaged due to cuff nicks from teeth or instrumentation during intubation.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX BLUE LINE PDT DIRECTIONAL TUBE
• Common Device Name: TUBE, TRACHEAL (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; rosengatan; minneapolis, MN 55442
• MDR Report Key: 15709867
• Report Number: 3012307300-2022-26576
• Device Sequence Number: 12045106
• Product Code: BTR
• UDI-Device Identifier: 15019315020377
• UDI-Public: 15019315020377
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K931735
• 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): 04/04/2023

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: 03/14/2023
• Device Model Number: 100/133/080
• Device Catalogue Number: 100/133/080
• Device Lot Number: 3598049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2022
• 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: 10/04/2022
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2018
• 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: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White