MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX PVC ORAL/NASAL TRACHEAL TUBES BLUE LINE; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/199/060
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device is marked 6.0, but is marked 6.5 on the surface of the product.Patient involvement is unknown.
Additional Manufacturer Narrative
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
Email is: regulatory.Responses@icumed.Com.A returned sample was received in use conditions with the original packaging opened.Two photos were included for evaluation, photos showed the complaint sample.The returned samples were visually inspected and the complaint was confirmed.Based on the analysis performed on the sample provided and the reported by the customer, the incorrect size of tracheal tube failure mode was confirmed.The cause was due to an assembly error by the manufacturer.Corrective actions are in process, in which the correct root cause for the reported condition will be determined.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: PORTEX PVC ORAL/NASAL TRACHEAL TUBES BLUE LINE
• 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: 17608010
• Report Number: 3012307300-2023-08367
• Device Sequence Number: 6139428
• Product Code: BTR
• UDI-Device Identifier: 15019315022302
• UDI-Public: 15019315022302
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K790312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

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: 05/12/2026
• Device Catalogue Number: 100/199/060
• Device Lot Number: 4124788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/03/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2021
• 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