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

Catalog Number	100/133/070
Medical Device Problem Codes	Material Puncture/Hole (1504); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: other; device not returned to manufacturer.No product or photos were 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 polar north 7.0 tube with cuff appeared punctured with significant leak during mechanical ventilation and inability to properly inflate the cuff.It was informed that it was "repaired" during the procedure.There is no sample available for evaluation.There was patient involvement and no harm or adverse event.

• Brand Name: PORTEX ENDOTRACHEAL TUBES POLAR
• 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: 18934246
• Report Number: 9617604-2024-00236
• Device Sequence Number: 4449529
• Product Code: BTR
• UDI-Device Identifier: 15019315020353
• UDI-Public: (01)15019315020353(17)270309(10)4250659
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 03/19/2024

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: 100/133/070
• Device Lot Number: 4250659
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2022
• 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