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

Model Number	100/189/085
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon deflated more often than usual.The user had to re-inflate it every 4 hours and sometimes the user had to put a cap on to limit leakage.It was confirmed that the user used rush "silicospray".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.Seven (7) product samples were received for evaluation.Visual and functional testing were performed.Visual inspection found no defects.Functional testing was performed by connecting the samples to the uson machine to identify any occlusion and no leaks were detected in the returned samples; the complaint was not confirmed.Samples passed all functional testing.No problem found.Root cause cannot be determined as the samples were successfully tested and no discrepancies were detected.
Additional Manufacturer Narrative
Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).

• Brand Name: PORTEX SACETT SUCTION ABOVE CUFF ENDOTRACHEAL TUBE
• 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: 14102339
• Report Number: 3012307300-2022-06294
• Device Sequence Number: 4805739
• Product Code: BTR
• UDI-Device Identifier: 15019315059551
• UDI-Public: 15019315059551
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2023

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: 08/10/2026
• Device Model Number: 100/189/085
• Device Catalogue Number: 100/189/085
• Device Lot Number: 4175600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2022
• Supplement Date Received by Manufacturer: 06/17/2022; 04/21/2023
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 07/11/2022; 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2021
• 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