MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX UNCUFFED CLEAR PVC SOUTH POLAR PREFORMED M; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/134/045
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the pre-use check, a part of the tube was found deformed or kinked.No patient injury.
Additional Manufacturer Narrative
H10: device evaluation: three photos were included in agile attachments for evaluation; photos showed a bit kink in curvature.One sample was returned for investigation.The returned sample was received in used condition without original packaging.The sample was visually inspected under normal conditions of illumination to detect any condition that could cause the failure mode reported.No discrepancies were found.The returned sample was inflated using a syringe and was submerged under water to detect any leak.No leakage was detected.No other analysis was performed.Based on the analysis conducted in the sample provided, kinked failure mode was confirmed.The failure condition was possibly due to packaging method not followed correctly (tube not placed properly on curving plate).Failure was traced to manufacturing.For corrective action an awareness notification was performed to personnel to explain the importance of adherence to manufacturing 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 UNCUFFED CLEAR PVC SOUTH POLAR PREFORMED M
• 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; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 14699341
• Report Number: 3012307300-2022-11975
• Device Sequence Number: 6692768
• Product Code: BTR
• UDI-Device Identifier: 15019315020865
• UDI-Public: 15019315020865
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/12/2023

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: 11/10/2025
• Device Model Number: 100/134/045
• Device Catalogue Number: 100/134/045
• Device Lot Number: 4062691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/18/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2020
• 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