MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX ENDOTRACHEAL TUBES MAXILLO FACIAL N/NASAL; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/133/070
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: other; device not returned to manufacturer.One (1) photo 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, has not been received.The customer reported that the involved device was thrown away as it had come into contact with patient body fluids.Unable to confirm the reported complaint because the device was not returned, and the reported failure mode is not seen in the photograph that was provided.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.
Event or Problem Description
It was reported that the cuff runs empty and there was an air leak from the side of the cuff.The issue of the leaking cuff was discovered in the operating room after intubation.It was stated that the patient had to reintubate two times, intubated with a straight tube through the mouth.There was patient involvement and there was patient harm reported.Adverse patient effects are unknown.

• Brand Name: PORTEX ENDOTRACHEAL TUBES MAXILLO FACIAL N/NASAL
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19206614
• Report Number: 3012307300-2024-03169
• Device Sequence Number: 7927039
• Product Code: BTR
• UDI-Device Identifier: 15019315020353
• UDI-Public: (01)15019315020353(17)280216(10)4364631
• Combination Product (Y/N): N
• Initial Reporter Country: EN
• 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: User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2024

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: 100/133/070
• Device Lot Number: 4364631
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2023
• 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