MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ENDOBRONCHIAL TUBES; 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	05/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical intubation|portex endobronchial tubes leaked.Reported during the use of the product, the customer found leakage of air from the cuff.No patient injury.
Additional Manufacturer Narrative
Other, other text: investigation completed on a smith medical intubation|portex endobronchial tubes one picture attached and in picture from p/n 195-32l l/n 3955980 is observed, no damage could be detected.Functional testing: the returned sample was inflated using a syringe and was submerged under water to detect any leak.No leaks were observed.No root cause could be determinate since sample successfully passed leak test.The device passed all functional testing prior to release.
Event or Problem Description
Investigation completed and summary in h 10.
Additional Manufacturer Narrative
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 record review.One sample was received in used conditions, with its opened original packaging for investigation.The returned sample was inflated using a syringe and was submerged under water to detect any leak.No leaks were detected after submerged under water; the complaint was not confirmed.No root cause could be determinate since sample successfully passed leak test.No action taken was performed since the complaint was not confirmed.

• Brand Name: PORTEX ENDOBRONCHIAL TUBES
• 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; 2-12-12, kitanagase-omotemachi; minneapolis, MN 55442
• MDR Report Key: 12044258
• Report Number: 3012307300-2021-06396
• Device Sequence Number: 4199237
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,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 Expiration Date: 03/18/2023
• Device Model Number: 198-32L
• Device Catalogue Number: 198-32L
• Device Lot Number: 3955980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 07/25/2021; 04/21/2023
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 08/24/2021; 04/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2020
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Race: Asian