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

Model Number	100/199/085
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the use of the product, leakage of air from it was observed.No patient injury reported.
Additional Manufacturer Narrative
Device serial number/lot number is unknown, no product information has been provided to date.A product sample was received and is awaiting evaluation and investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
Other text: h6: evaluation codes: updated.Device evaluation: two photos were included for evaluation; photos showed the complainant sample.One sample was returned for evaluation.It was received in used conditions without original package.The returned sample was visually inspected at 12" to 16" and normal conditions of illumination to detect any condition that could cause a leak.Leakage was detected between the check valve and pilot balloon.The customer's complaint was confirmed.Based on the analysis conducted it was determined that the failure mode was caused by manufacturing method not being followed.There was not enough solvent at the joint.The root cause was determined to be the lack of solvent at the joint.The lot number of the device was not provided therefore no device history review (dhr) could be completed.

• Brand Name: PORTEX ENDOTRACHEAL TUBES
• 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; 7-15-26 fukushima; minneapolis, MN 55442
• MDR Report Key: 16062518
• Report Number: 3012307300-2022-28224
• Device Sequence Number: 17814105
• Product Code: BTR
• UDI-Device Identifier: 15019315022357
• UDI-Public: 15019315022357
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K790312
• 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): 02/23/2023

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: 100/199/085
• Device Catalogue Number: 100/199/085
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/06/2022
• 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: 12/05/2022
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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