MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX TUBES BLUE LINE ULTRA (BLU); TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	100/856/080
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inner packaging of the device was labelled as a size 8mm inner cannula however, upon opening the package, discovered a size 9mm inner cannula inside.No patient injury was reported.
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).G5 510k is unknown.No information has been provided to date.A review of the device history records showed there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.No product sample was received; therefore, visual and functional testing could not be performed.The investigation of this complaint was done based on photo.From photographs received for evaluation, it was observed that the package indicates an 8.0 mm inner cannula and the cannula packaged was a 9.0 mm inner cannula.In order to verify that there are no situations or practices that could create/generate the event as described in description of non-conformance section an audit of the production floor was conducted by the quality engineer and there were no discrepancies that were found.32 samples were reviewed during manufacturing process and 100 percent visual inspected verify the cannula size and color are the correct ones according to flow chart and product labels.Result: no discrepancies were found.A correction action plan was opened and presented to the manufacturing personnel by the quality engineer in order to create awareness about the failure mode reported by the customer.The root cause was related to manufacturing.

• Brand Name: PORTEX TUBES BLUE LINE ULTRA (BLU)
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15591745
• Report Number: 3012307300-2022-23617
• Device Sequence Number: 2215862
• Product Code: JOH
• UDI-Device Identifier: 55019315052628
• UDI-Public: 55019315052628
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/12/2022

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: 02/08/2023
• Device Model Number: 100/856/080
• Device Catalogue Number: 100/856/080
• Device Lot Number: 3578884
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2018
• 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