MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ENDOTRACHEAL TUBES POLAR; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/136/050
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the pre-use check, the customer noticed the cuff was unable to be inflated.No patient injury.No additional information is available for this complaint.
Event or Problem Description
It was reported that during the pre-use check, the customer noticed the cuff was unable to be inflated.No patient injury.No additional information is available for this complaint.
Additional Manufacturer Narrative
H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Photos received: two (2) photos were included in agile attachments for evaluation.Results: line occluded was detected in photo 1.Sample returned: one (1) sample was returned for evaluation p/n 100/136/050; the sample was received in used conditions without its original package.Visual inspection: the returned sample was visually inspected at 12? to 16? and normal conditions of illumination.Results: line occluded was detected.Functional testing: the returned sample was inflated using a syringe results: cuff won?t inflate; the complaint was confirmed.Leak testing: the sample returned was connected to leak tester machine [cal id: 8.1597, due date: march,2022] to identify any occlusion.Results: occlusion was detected.Based on the analysis conducted in the sample provided, cuff inflation/deflation failure mode was confirmed.Therefore, according to on pfmea (rmp 1051) the occurrence of this failure condition could be caused by: mp tmfl-tj120? tracheal manual flow line ? bell-out and leak test? rev 107; section 2.5 not followed properly.The cause of the reported problem was traced to the manufacturing process.Any relevant dmrs, ncrs, ets, etc.: there were no issues, nonconformance reported during the manufacture of this lot.

• Brand Name: PORTEX ENDOTRACHEAL TUBES POLAR
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; aichi pref.; minneapolis, MN 55442
• MDR Report Key: 13392433
• Report Number: 3012307300-2022-02173
• Device Sequence Number: 11880045
• Product Code: BTR
• UDI-Device Identifier: 15019315021053
• UDI-Public: 15019315021053
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K931735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

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 Model Number: 100/136/050
• Device Catalogue Number: 100/136/050
• Device Lot Number: 4062692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown