MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX TUBES BLU SELECT; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	101/815/080
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the lot number on flange was not matching the lot number on the box.Issue was detected prior to use with the patient.No patient injury or involvement was reported.
Additional Manufacturer Narrative
Samples received for evaluation in used conditions, decontaminated inside a plastic bag.No root cause must be determined since the complaint was not confirmed since no issues were found with the product, the lot number on flange is not equal to box/packaging lot number due this is the process from design.A review of the manufacturing process for was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.No discrepancies were found.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).

• Brand Name: PORTEX TUBES BLU SELECT
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15410081
• Report Number: 3012307300-2022-18888
• Device Sequence Number: 6999392
• Product Code: BTO
• UDI-Device Identifier: 15019517077360
• UDI-Public: 15019517077360
• Combination Product (Y/N): N
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2022

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
• Device Expiration Date: 11/08/2024
• Device Model Number: 101/815/080
• Device Catalogue Number: 101/815/080
• Device Lot Number: 3905015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2019
• 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