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

Catalog Number	100/133/075
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an anesthesiologist intubated a patient with a size 7.5 tube for facio-maxillary surgery, and while attempting to inflate the cuff, it was noticed that there was a leak.The tube was removed from the patient and then intubated using a new size 7.5 tube and the same issue was experienced.The patient was intubated with a size 7.0 tube and the same issue was experienced.Care was taken on intubation and no forceps or otherwise were used that could have damaged any of the cuffs.Following this incident, all three defective tubes were tested underneath water and found that all three leaks appeared to be on the seal of the cuff itself.There was patient involvement and no patient harm reported.
Additional Manufacturer Narrative
H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.Investigation summary: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Additional Manufacturer Narrative
Investigation summary: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: PORTEX MAXILLOFACIAL ENDOTRACHEAL TUBE, CUFFED
• 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19536949
• Report Number: 9617604-2024-00527
• Device Sequence Number: 8338009
• Product Code: BTR
• UDI-Device Identifier: 15019315020360
• UDI-Public: (01)15019315020360(17)280801(10)4419510
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2024

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 Catalogue Number: 100/133/075
• Device Lot Number: 4419510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2024
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown