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

Model Number	100/179/055
Medical Device Problem Codes	Inflation Problem (1310); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the use of the product (an endotracheal tube), the customer noticed air was unable to be put in the cuff.So he removed it from the patient and submerged it in water.As a result, air bubbles came out of the tube tip.Also, water went into the pilot balloon.Additionally it was reported that a new tube was chosen and placed.No patient injury.
Additional Manufacturer Narrative
H10: device evaluation: the sample was returned for investigation.The sample was received in used condition without its original packaging open and inside in a plastic bag.The samples were visually inspected under normal conditions of illumination to detect sample conditions that could cause functional issues.A rip was found on tube tip; the complaint was confirmed.A syringe was connected to pilot balloon to allow air through the tube to confirm the place of the leak.The failure mode was traced to manufacturing (damaged) and inspection procedures not followed properly.For corrective action, a customer complaint notification was made to production personnel to explain the importance of adherence and following the procedure.A dhr review could not be performed in that no specific product was identified.No serial number was provided.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX ENDOTRACHEAL TUBE W/HOLDER AND CONNECTOR
• 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; 7-1-1 akasaka,; minneapolis, MN 55442
• MDR Report Key: 15166743
• Report Number: 3012307300-2022-14728
• Device Sequence Number: 11962205
• Product Code: BTR
• UDI-Device Identifier: 15019315022098
• UDI-Public: 15019315022098
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K790312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 100/179/055
• Device Catalogue Number: 100/179/055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2022
• Supplement Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown