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

Model Number	505070
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon was leaking on the device.No patient injury was reported.
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).There were no non-conforming reports (ncrs) initiated for the lot or anomalies identified in the device history record (dhr) review.A product sample was received for evaluation without its original packaging and in used condition.Visual and functional testing were performed.Visual inspection revealed what appeared to be a small opening at the weld area of the cuff during the functional testing the cuff was inflated using 1.5 pounds per square inch of air.The entire tracheostomy tube was submerged under water while observing for signs of leakage (bubbles rising to the surface of the water), from all aspects of the tracheostomy device.This test revealed leakage from the tracheostomy tube, located at the weld area furthest from the tip (patient end).Further investigation using magnification revealed that the cuff did not appear to be adequately cemented to the outer tube.The cuff was easily moved along the outer tube at this location.The weld area located closest to the tip appeared to be cemented properly and remained adhered following the decontamination process, indicating that the leakage may have been the result of an assembly error the root cause was related to product assembly during the manufacturing process.A quality alert was issued to production to heighten awareness to this potential issue.Complaint information will continue to be monitored for any new information or adverse trends and further actions will be taken accordingly.

• Brand Name: PORTEX TUBES DIC
• 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): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; building 2; minneapolis, MN 55442
• MDR Report Key: 15596376
• Report Number: 3012307300-2022-23785
• Device Sequence Number: 2328435
• Product Code: BTR
• UDI-Device Identifier: 10351688000231
• UDI-Public: 10351688000231
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K934465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/13/2022

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: 09/10/2021
• Device Model Number: 505070
• Device Catalogue Number: 505070
• Device Lot Number: 3355447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2017
• 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 Age: 12 YR
• Patient Sex: Male