MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION

Model Number	198-32L
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the use of the product, leakage of air from the blue cuff was observed.No patient injury was reported.
Event or Problem Description
It was reported that during the use of the product, leakage of air from the blue cuff was observed.No patient injury was reported.
Additional Manufacturer Narrative
Other text: this remediation mdr was generated under protocol(b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history review.Four photos were included in agile attachments for evaluation and a small hole was detected in pilot balloon.One sample was returned for evaluation; the sample was received in used conditions without original package.The returned sample was visually inspected under normal conditions of illumination.It was noticed that there was a small hole detected in pilot balloon.During functional testing, the sample was leak tested by connection to a leak tester machine to identify any leaks.A leak on the pilot balloon was detected; the complaint was confirmed.The sample returned was verified in the pressure decay test that is capable of detecting the leak that caused the hole.Operations prior to the pressure decay test was reviewed and it was confirmed that there were no sharp surfaces that could cause the hole that is shaped as a pin hole.This indicates that the damage could be caused after the manufacturing process.No action was taken since cannot be confirmed that the failure mode was caused during the manufacturing process.

• Brand Name: PORTEX
• Common Device Name: TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION
• 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; akasaka, minato-ku, tokyo; minneapolis, MN 55442
• MDR Report Key: 13586552
• Report Number: 3012307300-2022-03983
• Device Sequence Number: 14834516
• Product Code: CBI
• UDI-Device Identifier: 15019315058608
• UDI-Public: 15019315058608
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K953483
• 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): 04/30/2023

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: 198-32L
• Device Catalogue Number: 198-32L
• Device Lot Number: 4133894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 04/30/2023
• 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
• Patient Sex: Unknown