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	03/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: other; device not returned to manufacturer.Device evaluation: no product was returned therefore no device analysis could be completed.A device history record (dhr) review showed there were no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.
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 patient had to reintubated 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.The device is not available for investigation because it was thrown away due to coming into contact with patient body fluids.

• 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: 19134805
• Report Number: 3012307300-2024-02721
• Device Sequence Number: 4658630
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/18/2024

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: 03/21/2024
• Initial Report FDA Received Date: 04/18/2024
• 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