MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. SILICONISED PVC ORAL/NASAL SOFT CUFF TRACHEAL; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/179/065
Medical Device Problem Codes	Deflation Problem (1149); Unintended Deflation (4061)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	03/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
Event or Problem Description
It was reported that the patient was hypoxic.A doctor did a bedside nasal tracheal intubation and no issues were found.After one hour in use, the cuff was deflated significantly.No patient harm was reported.
Additional Manufacturer Narrative
Health impact code: updated based on new information received.
Event or Problem Description
Additional information received via email.A trach change was performed.
Additional Manufacturer Narrative
Email is: regulatory.Responses@icumed.Com.One (1) video was provided by the customer which was used to conduct the device analysis since the physical unit, by the time this investigation is being documented, had not been received.The video shows tracheal tube with the cuff inflated submerged under water, at a slow rate air bubbles come out from the junction between the cuff and tracheal tube.Later in the video the device is manipulated, and the air bubbles are observed to come out at a higher rate.The was confirmed.A root cause could not be determined.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.Mitigations in place were revised and are being executed as is determined by procedure.This failure will continue to be monitored to determine if new actions needs to be taken.

• Brand Name: SILICONISED PVC ORAL/NASAL SOFT CUFF TRACHEAL
• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 16856363
• Report Number: 3012307300-2023-04938
• Device Sequence Number: 6865298
• Product Code: BTR
• UDI-Device Identifier: 15019315022111
• UDI-Public: 15019315022111
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K790312
• 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): 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/02/2025
• Device Model Number: 100/179/065
• Device Catalogue Number: 100/179/065
• Device Lot Number: 3969685
• Was Device Available for Evaluation?: No
• 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: 04/18/2023
• Supplement Date Received by Manufacturer: 05/10/2023; 06/15/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 05/26/2023; 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male