MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX TRACHEAL TUBE SILICONIZED ORAL/NASAL UN-CUF; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/111/025
Medical Device Problem Codes	Crack (1135); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device lot number is unknown, no product information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
Event or Problem Description
It was reported that the trach tube had a crack in the blue hub, and a gaping hole was observed.The product had no defects when taken out of the packet.The blue plastic hub was left in the endo tracheal tube and could not be removed, it was completely stuck.This caused the user to have to reintubate the patient.Additional information was received via customer response email 20-sep-2022 stating the issue was discovered immediately after intubation of the patient, upon having no pedicap change despite the tube clearly being thru the cords, lot number is not known.There has been no report of observable clinical symptoms or a change in symptoms identified in the patient after the completion of the re-intubation.
Additional Manufacturer Narrative
Event problem and evaluation codes: updated.H3: device evaluated by manufacturer: updated two (2) photos were attached to the complaint created; photos showed damage to the tube tip.Per photos received, a broken connector was detected; the complaint was confirmed.No other analysis was performed.Based on the analysis conducted in the sample provided, the failure mode reported was confirmed, and the occurrence of this failure condition could be caused by mishandling of the device.The root cause was traced to manufacturing.For corrective action, a customer complaint notification was made to production personnel to explain the importance of following or adhering to the manufacturing procedure.No lot number was provided; therefore, device history record review could not be completed.This remediation mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX TRACHEAL TUBE SILICONIZED ORAL/NASAL UN-CUF
• 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; minneapolis, MN 55442
• MDR Report Key: 15577446
• Report Number: 3012307300-2022-23205
• Device Sequence Number: 6763517
• Product Code: BTR
• UDI-Device Identifier: 15019315018848
• UDI-Public: 15019315018848
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K790312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• 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 Model Number: 100/111/025
• Device Catalogue Number: 100/111/025
• Was Device Available for Evaluation?: No
• 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: 09/13/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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