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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the customer put air in the cuff during the pre-use check, leakage from the product was observed.No patient involvement.
Additional Manufacturer Narrative
Other text: four (4) photos were received for evaluation; damage on tube tip was observed in photo 4.One sample was received.The returned sample was visually inspected; a big cut from the tip of the tube was found.The device underwent functional testing.An air leak was detected in the tube tip where the cut was detected; the complaint was confirmed.Root cause was determined to be production procedure not followed properly.An awareness notification was made to production personnel by quality engineer on 13/jun/2022.There were no non-conforming reports (ncrs) initiated for the lot or anomalies identified in the device history record review.The lot met the requirements for release.No deviations identified during manufacturing., corrected data: d4 and h4.

• 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; 2-12-12, kitanagase-omotemachi; minneapolis, MN 55442
• MDR Report Key: 14014196
• Report Number: 3012307300-2022-05833
• Device Sequence Number: 12337580
• 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): 10/13/2022

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 Expiration Date: 01/26/2026
• Device Model Number: 100/136/050
• Device Catalogue Number: 100/136/050
• Device Lot Number: 4080567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2022
• 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: 03/07/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2021
• 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