MAUDE Adverse Event Report: NULL PORTEX; TUBE, TRACHEOSTOMY

Model Number	101/860/080
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspection were completed and no issues were noted during manufacture.The unit box and individual package were returned.As a result of the inspection of the returned package, the product and lot number of the package, the contents, and the japanese label were matched.A review of labeling process of this product at komaki found that the individual package is placed into the new japan unique shelf box from the original box supplied by tijuana and japanese label is placed on the japan unique shelf box.This indicates that there is no abnormality in manufacturing.Review of manufacturing records, relevant to the lot reported, found no discrepancies or anomalies.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that the outer box label indicated product was 100/860/080 however, the inner package contains product 100/860/070.No patient injury was reported.

• Brand Name: PORTEX
• Common Device Name: TUBE, TRACHEOSTOMY
• Manufacturer (Section G): NULL
• MDR Report Key: 15410054
• Report Number: 3012307300-2022-18884
• Device Sequence Number: 12448744
• Product Code: BTO
• UDI-Device Identifier: 15019517077933
• UDI-Public: 15019517077933
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• 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: 05/23/2024
• Device Model Number: 101/860/080
• Device Catalogue Number: TUBE, TRACHEOSTOMY
• Device Lot Number: 3810229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• 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: 06/17/2019
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown