MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX SACETT SUCTION ABOVE CUFF ENDOTRACHEAL TUB; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/189/070
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tube was checked and an air leak was found in the airbag.No patient injury was reported.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product sample was received for evaluation; however, a review of the manufacturing process was performed.No discrepancies were detected during visual inspection.No discrepancies were found during the inspection test.No root cause could be determined since the complaint could not be confirmed since no samples or pictures were received for evaluation.Operator of the device is unknown.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.

• Brand Name: PORTEX SACETT SUCTION ABOVE CUFF ENDOTRACHEAL TUB
• 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): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15289618
• Report Number: 3012307300-2022-16130
• Device Sequence Number: 2504594
• Product Code: BTR
• UDI-Device Identifier: 15019315059520
• UDI-Public: 15019315059520
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081086
• 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
• Report Date (Section B): 08/25/2022

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
• Device Expiration Date: 10/23/2022
• Device Model Number: 100/189/070
• Device Catalogue Number: 100/189/070
• Device Lot Number: 3514620
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2017
• 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
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male