MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PVC - PORTEX TUBES DIC; TUBE, TRACHEAL

Model Number	505070
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.The device history record (dhr) review found no discrepancies or anomalies relevant to the complaint.In-process, the product was checked for function (inflation retention) with water and air dry test and no non-conformities were noted.In-process, the product was inspected for any visible damages that compromise function based on c=0 (critical) and no non-conformities were noted.Received for investigation: one decontaminated sample in its original packaging, but the packaging was opened with the tyvek lid missing.The sample showed no signs of having been used.Visual inspection of the cuff revealed no anomalies or defects.The cuff appeared to be attached properly and was not obstructing the end of the tube.Functional testing, a leak test, was performed and no leakage was observed and the cuff appeared inflated properly.Based on the evaluation of returned sample, the reported problem could not be confirmed and the root cause could not be determined.Complaint information will continue to be monitored for any new information or adverse trends and further actions will be taken accordingly.
Event or Problem Description
It was reported that, prior to using the trach tube-inflated cuff, the cuff appeared to be misshaped so the device was not used.No patient injury was reported.

• Brand Name: PVC - PORTEX TUBES DIC
• Common Device Name: TUBE, TRACHEAL
• 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; minneapolis, MN 55442
• MDR Report Key: 16052345
• Report Number: 3012307300-2022-28160
• Device Sequence Number: 6394798
• Product Code: BTR
• UDI-Device Identifier: 10351688000231
• UDI-Public: 10351688000231
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K934465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2022

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 Model Number: 505070
• Device Catalogue Number: 505070
• Device Lot Number: 4168583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown