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

Model Number	100/189/080
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product sample was received and is awaiting evaluation, investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the endotracheal tube was kinked.It was not possible to get air into the patient during intubation.There has been no report of patient injury or no observable clinical symptoms or a change in symptoms identified in the patient.
Additional Manufacturer Narrative
Device evaluation: one used device was received for investigation.No damage or anomalies were observed during visual inspection, however, the reported issue was confirmed during functional testing when the device cuff was inflated but failed to maintain pressure.The investigation attributed the root cause of this condition to incorrect use of the product.Review of manufacturing device history records found no related non-conformances.As no manufacturing root cause was found, no actions have been assigned at this time.

• Brand Name: SACETT SUCTION ABOVE CUFF ENDOTRACHEAL TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16639444
• Report Number: 3012307300-2023-03236
• Device Sequence Number: 20467778
• Product Code: BTR
• UDI-Device Identifier: 15019315059544
• UDI-Public: 15019315059544
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

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: 05/13/2025
• Device Model Number: 100/189/080
• Device Catalogue Number: 100/189/080
• Device Lot Number: 3973442
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2020
• 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