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

Model Number	100/199/065
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction
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 cuff of the endotracheal tube was found leaking after intubation.No patient harm reported.
Event or Problem Description
Additional information received confirming there was no patient harm.No medical intervention required.The outcome of the event was resolved.
Additional Manufacturer Narrative
No device was returned for investigation.Instead, two photos and one video were sent in.The video showed a tracheal tube inflation line being connected to a syringe and being inflated with air.The cuff and pilot balloon were inflating.The pilot balloon was submerged under water and air bubbles were observed to come out of the proximal end near the check valve.This confirmed the customer complaint of leakage.Photo one shows packaging and photo two shows a close up of the pilot balloon submerged in water where air bubbles were observed again.The manufacturing process for detecting leaks was reviewed and without the device, no root cause could be determined.Device history review showed no non-conformities during the manufacturing process.

• 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: 16869477
• Report Number: 3012307300-2023-05074
• Device Sequence Number: 20322949
• Product Code: BTR
• UDI-Device Identifier: 15019315022319
• UDI-Public: 15019315022319
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/23/2023

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 Model Number: 100/199/065
• Device Catalogue Number: 100/199/065
• Device Lot Number: 4220262
• Was Device Available for Evaluation?: No
• 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: 04/21/2023
• Supplement Date Received by Manufacturer: 06/01/2023; 06/19/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 06/13/2023; 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2021
• 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