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

Catalog Number	100/136/050
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a hole in the tube next to the blue line for cuff inflation.The hole itself is not visible, but it was detected by the machine after intubation.The error was reported by the ventilator and the clinician had to reintubate the patient.After checking a few other tubes, the customer found a similar problem in 2-3 samples.Device is not available for investigation since they did not save the samples, but a photo was provided.Medical intervention was required since the patient needed to be reintubated.The outcome of the event was resolved.There was patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
E1: (b)(6).Device evaluation: two photos were provided for evaluation.The indent was observed on the tube near the inflation line; subassembly is assembled.The failure mode of ¿a0062 - breakage/cut" was confirmed.
Additional Manufacturer Narrative
Three units and two photos were returned for evaluation.Indent was observed on tube near of the inflation line subassembly is assembled.Breakage/cut issue was confirmed.The root cause was unknown.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.
Additional Manufacturer Narrative
H6.Codes: updated.Additional device evaluation: the root cause of the issue was manufacturing; the knives that cuts the plastic tube is ¿wear with the dice¿ which allows to replicate the failure mode and if the mark tube is not correctly aligned when inserted for cut operation, which allows to replicate the failure mode.Action taken: fix with external supplier, training operators and clarify procedures to include pictures.

• 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: 19525133
• Report Number: 9617604-2024-00526
• Device Sequence Number: 7704575
• Product Code: BTR
• UDI-Device Identifier: 15019315021053
• UDI-Public: (01)15019315021053(17)280301(10)4364635
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2025

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: 100/136/050
• Device Lot Number: 4364635
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 08/02/2024; 02/19/2025
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 08/30/2024; 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2023
• 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
• Patient Sex: Unknown