MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. PORTEX TRACHEAL TUBE MAXILLO FACIAL; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/133/065
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: month and year of event have been provided; day is unknown.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 a cuff leak occurred.This occurred during patient use at the facility.There was a patient involvement and no harm/adverse event reported.There was no disinfection or sterilization, and no infectious disease occurred.
Additional Manufacturer Narrative
H3 and h6.Evaluation codes: updated.One device sample was received in used condition, in a plastic bag without the original packing.During visual inspection, damage (scratches) were identified on the surface of the cuff.A leak test was performed, and the sample failed to stay inflated.A leak was confirmed in the cuff.Based on the analysis performed on the sample, the type of scratch observed can be caused when the cuff inflated is in contact with some sharp edge, the unit is observed used, it seems that it got stuck during the intubation process and when pulling the device caused this leak.However, root cause cannot be associated with the manufacturing process since the failure reported could not be reproduced using the tools from assembly process.The issue will be monitored for threshold or escalation.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: PORTEX TRACHEAL TUBE MAXILLO FACIAL
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19306231
• Report Number: 9617604-2024-00430
• Device Sequence Number: 12592942
• Product Code: BTR
• UDI-Device Identifier: 15019315020346
• UDI-Public: (01)15019315020346(17)280808(10)4421896
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K931735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2024

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 Catalogue Number: 100/133/065
• Device Lot Number: 4421896
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/07/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown