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	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a white looking powder was found on the balloon cuff of the tubes.No patient injury was reported.
Additional Manufacturer Narrative
Other, other text: this mdr was generated under protocol b10010116, as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.A product sample was received for evaluation.Visual and functional testing were performed.Twenty samples were returned for evaluation.The samples were received in unused conditions within original package.The returned samples were visually inspected at 12 to 16 inches and normal conditions of illumination.While spots condition found on cuff in the twenty samples and the white spots stuck on the tape.The reported issue was confirmed.A retrospective review was conducted to understand if a trend could be identified on the reported failure mode.The results showed that, with the information available of the reported complaints, the manufacturing date on the affected lots were for a period between november 2019 and june 2021; therefore, this was considerate an isolated condition that needs to be escalated to formal investigation to identify the root cause.An alert was generated as an awareness notification about white powder in the cuff.This alert was placed in the molding and assembly line.A non-conformance report was opened to investigate the presence of white powder in the cuff.A supplier corrective action request was opened for the supplier to investigate the raw material as a potential variable in the presence of the white powder.

• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 16841287
• Report Number: 3012307300-2023-04778
• Device Sequence Number: 15175774
• Product Code: BTR
• UDI-Device Identifier: 15019315022357
• UDI-Public: 15019315022357
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K790312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/30/2023

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 Expiration Date: 03/18/2025
• Device Model Number: 100/199/085
• Device Catalogue Number: 100/199/085
• Device Lot Number: 3962921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 04/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown